COVID-19

COVID Weekly Recap: FDA looking to develop additional standards for COVID-19; WHO issues standards for emergency use of vaccines

Top stories: · FDA wants to set standards for COVID-19-related viral pneumonia treatment processes · Real-world evidence for the COVID-19 vaccine: Understanding bias and tracking abilities will be key · WHO publishes vaccine guidance containing standards for emergency use · CDER data offers first glimpse at the impact of its compounding enforcement discretion policy on …

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COVID Weekly Recap: The need for transparency in COVID development. International COVID test standard on its way. COVID shows the need for a quality rating system.

Top stories: · Development secrecy vs. a public’s right to know: An argument erupts · IVD Chief: International COVID test standard likely available by end of year · FDA issues report on comparative performance of certain COVID-19 diagnostics · Hahn: COVID shows need for US manufacturing and a quality rating system · FDA Device leadership …

COVID Weekly Recap: The need for transparency in COVID development. International COVID test standard on its way. COVID shows the need for a quality rating system. Read More »

COVID Weekly Recap: FDA rejects Oleandrin as a supplement. Legislators probe FDA on transparency.

Top stories: FDA denies new dietary ingredient application for Oleandrin. Legislation seeks to bolster public confidence in FDA vaccine decision with transparency. Legislators question communications process for EUA modifications. BIO, biotech executives advocate for ‘historic independence’ of FDA. Is the FDA’s approach to quality metrics due for a comeback? Welcome to our COVID Weekly Recap, …

COVID Weekly Recap: FDA rejects Oleandrin as a supplement. Legislators probe FDA on transparency. Read More »

COVID Weekly Recap: A significant change to FDA’s authority over laboratory tests. New guidance on FDA inspections. FDA clarity on diagnostic and face mask policies.

Top stories: FDA officially schedules its AdComm for COVID vaccines. Convalescent plasma has a diagnostics problem. FDA still silent on HHS’ laboratory developed test policy. FDA asks Supreme Court to lift injunction. Welcome to our COVID Weekly Recap, AgencyIQ’s weekly wrap-up of the top regulatory developments related to COVID-19. The following analysis was available to …

COVID Weekly Recap: A significant change to FDA’s authority over laboratory tests. New guidance on FDA inspections. FDA clarity on diagnostic and face mask policies. Read More »

COVID Weekly Recap: A significant change to FDA’s authority over laboratory tests. New guidance on FDA inspections. FDA clarity on diagnostic and face mask policies.

  Top stories: HHS unveils new approach for FDA’s oversight of laboratory developed tests. FDA releases details about its facility inspections during COVID. Congress wants more information about HHS’ LDT policy change. FDA authorizes novel saliva-based COVID-19 diagnostic. Diagnostics lab meeting highlights continued confusion about “non-laboratory” and “at-home” testing. Legal experts offer recommendations for FDA …

COVID Weekly Recap: A significant change to FDA’s authority over laboratory tests. New guidance on FDA inspections. FDA clarity on diagnostic and face mask policies. Read More »

COVID Weekly Recap: FDA commits to a COVID advisory committee and political independence

Top stories: FDA says its Advisory Committee will review COVID vaccines. What Russia’s approval of a vaccine means for the FDA. FDA Commissioner says political pressure won’t affect vaccine decision. Updated guidance calls for testing of hand sanitizers. FDA issues umbrella authorization for certain face masks. Welcome to our COVID Weekly Recap, AgencyIQ’s weekly wrap-up …

COVID Weekly Recap: FDA commits to a COVID advisory committee and political independence Read More »

The FDA’s Complete Response Letter secrecy could be on a crash course with COVID

FDA regulators have long thought about ways to make Complete Response Letters more transparently available to both the public and industry. Now, interest in developing treatments for COVID-19 as quickly as possible may make that transparency more important than ever before.   By Aaron Badida, JD Regulatory Background Before the FDA can approve a medical …

The FDA’s Complete Response Letter secrecy could be on a crash course with COVID Read More »

Socially distant generic litigation: How COVID could slow FDA approvals

Generic drug approval applications that rely on the Paragraph IV certification process to invalidate patents may experience delays as courts contend with COVID-19 delays. What might this mean for litigants and approvals? By Aaron Badida, JD Background When Congress passed the Drug Price Competition and Patent Term Restoration Act of 1984 (better known as the Hatch-Waxman …

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3D printing during COVID tests FDA’s policies

The FDA has leaned on 3D printing to help alleviate shortages of essential medical equipment during COVID-19, but the broader use of the technology poses potential challenges for the agency. AgencyIQ explains the regulatory history behind 3D printing, as well as the challenges ahead. By Charles Friend Regulatory Background Additive manufacturing (AM) is a process …

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FDA clarifies “moderate” changes for already-approved devices under new COVID guidance

Manufacturers of Class III or Humanitarian Device Exemption (HDE)-eligible medical devices could see increased flexibility to keep manufacturing capacity up amid the pandemic under new guidance from the FDA. By Laura DiAngelo, MPH Executive IQ Brief How Things Work Now: Once a medical device has been approved (or similar), its sponsor must submit additional applications, known …

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As COVID restricts FDA travel, could its quality metrics proposal make a comeback?

After initially receiving negative feedback on its proposal to implement a quality metrics reporting program, the FDA’s proposed 2016 program could represent an effective means to getting around travel restrictions imposed by COVID-19.   By Aaron Badida, JD Background and Context The FDA regulates and inspects thousands of manufacturing, distribution, storage and dispensing facilities. While …

As COVID restricts FDA travel, could its quality metrics proposal make a comeback? Read More »

FDA provides further clarity on clinical trial adverse event reporting

Newly updated guidance from the FDA provides sponsors with additional details about how to report adverse events associated with COVID-19.   By Kedest Tadesse, MS, RAC  How Things Work Now In March 2020, the FDA issued a new guidance document, “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.” This guidance was …

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House COVID package looks to make improvements to shortage reporting and the supply chain

After the passage of the CARES Act in March, legislators in Congress are still working on packages to respond to the COVID-19 pandemic. The House’s version—set to be voted upon on Friday—includes several provisions on device and drug shortage reporting, bolstering the supply chain, and preventive/surveillance measures.   By Laura DiAngelo, MPH, and Aaron Badida, …

House COVID package looks to make improvements to shortage reporting and the supply chain Read More »

FDA responds to additional concerns about protocol modification due to COVID-19

COVID-19 has complicated the clinical trial landscape, in some cases requiring protocol deviations to ensure the integrity of the trial and patient safety. AgencyIQ explores three key policies advanced by FDA that can help sponsors keep clinical trials on track.   By Aaron Badida, JD How Things Work Now COVID-19 has disrupted hundreds of clinical …

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FDA releases long-awaited guidance on COVID-19 drug development

The guidance, intended to support companies racing to develop treatments for the novel coronavirus, outlines best practices for designing clinical trials that the FDA will consider sufficient to support approval. However, the guidance also notes several areas in which the agency is not yet providing recommendations, indicating that changes are yet to come. By Laura …

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FDA guidance on pre-IND meetings offers roadmap for expediting early development process for COVID-19

Following a series of updated and new guidance documents to address COVID-19, the FDA has released new recommendations on how sponsors can request early-stage meetings with the FDA and the data they’ll need to provide.   By Kedest Tadesse, MS, RAC   How things work now   Under the Prescription Drug User Fee Act (PDUFA), …

FDA guidance on pre-IND meetings offers roadmap for expediting early development process for COVID-19 Read More »

Congressional concerns about supply chain could create new requirements for FDA, industry

Three recently-introduced bills seek to study or transform the security of the US supply chain for pharmaceutical and biopharmaceutical products. AgencyIQ explains what they would do and their regulatory impacts.   By Aaron Badida, JD    Like many manufactured goods, the vast majority of common generic drugs and active pharmaceutical ingredients (APIs) in the US …

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COVID-19 vaccine development tracker

Companies are scrambling to put new vaccines into development to potentially prevent new infections by the SARS-CoV-2 virus. Based on a review by AgencyIQ of ClinicalTrials.gov, company announcements and media reports, there are at least 11 vaccines candidates in various stages of clinical testing to assess their potential safety and efficacy against SARS-CoV-2. Many of these …

COVID-19 vaccine development tracker Read More »

FDA diagnostics guidance updated to include antigen testing parameters

With the first antigen test for COVID-19 authorized over the weekend, the FDA released an updated guidance document containing information on how companies can submit an antigen test for emergency authorization.   By Laura DiAngelo, MPH How Things Work Now Since the declaration of a Public Health Emergency (PHE) for COVID-19 in February, the FDA …

FDA diagnostics guidance updated to include antigen testing parameters Read More »

FDA establishes new medical device shortage reporting requirements

Manufacturers of certain medical devices that are life-sustaining, life-supporting, or intended for use in emergency medical care are now subject to shortage reporting for the first time. The FDA issued guidance implementing the policy, which was introduced under the CARES Act in March.   By Laura DiAngelo, MPH Executive IQ Brief How Things Work Now: Although …

FDA establishes new medical device shortage reporting requirements Read More »

Amid mounting scrutiny, FDA overhauls antibody testing guidance

Serological (or “antibody”) tests are used to identify if an individual has had an immune response to a pathogen. A new FDA guidance document overturns existing FDA policy and requires that most marketed tests undergo the agency’s Emergency Use Authorization review procedure.   By Laura DiAngelo, MPH   Executive IQ Brief How Things Work Now: A …

Amid mounting scrutiny, FDA overhauls antibody testing guidance Read More »

FDA guidance permits exemptions from supply chain protection measures

Supply chain protection measures like “track and trace” help to protect against counterfeit drugs, but may also cause delays and bottlenecks during a public health emergency like COVID-19. The FDA has decided to temporarily exempt certain transactions in an effort to get treatments where they’re needed as quickly as possible.   By Aaron Badida, JD …

FDA guidance permits exemptions from supply chain protection measures Read More »

A new NIH-led interagency program aims to develop and scale up COVID-19 diagnostics

COVID-19 diagnostic developers could gain financial and operational manufacturing assistance and a regulatory fast-track through a new program announced by the NIH in collaboration with FDA and BARDA. While the Rapid Acceleration of Diagnostics (RADx) program is intended to incent developers to come up with novel solutions to ongoing testing capacity issues, the project’s success …

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With clinical trials facing challenges from COVID, the FDA offers additional clarity

Clinical trial sponsors are likely to face tough decisions in the coming months on whether to continue their investigations and how to maintain the integrity of their data. In a recent webinar, the FDA’s drug review center outlined best practices for companies to respond to COVID’s effects on their trials, but also stated that the …

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How the just-in-time economy failed to deliver against COVID-19

Drug and device manufacturers have relied on just-in-time manufacturing (JTM) manufacturing methods to reduce costs while maintaining product availability, but COVID-19 has shown one of the inherent weaknesses of this manufacturing approach: An inability to handle rapid, unexpected shifts in supply and demand. As Congress considers reforms to supply chain oversight, the FDA may have …

How the just-in-time economy failed to deliver against COVID-19 Read More »

With drug development topics in focus, lawmakers release updated 21st Century Cures 2.0 proposal

Following a call for comments late last year, Reps. Upton (R-MI) and DeGette (D-CO) released a new “concept paper” on an updated iteration of the landmark 21st Century Cures legislation. While the proposal addresses expected topics like real-world evidence and digital health, it now also seeks to address COVID-19 product development.   By Laura DiAngelo, MPH …

With drug development topics in focus, lawmakers release updated 21st Century Cures 2.0 proposal Read More »

FDA warns of COVID’s impact on generic drug studies required for approval

The novel coronavirus could disrupt generic drug companies’ plans to conduct studies to collect the data needed to support their applications for approval, the latest way in which the FDA has conceded life sciences companies are being affected by COVID-19.   By Alexander Gaffney, RAC The disruptions, noted by the FDA this week, could be felt …

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How should drugs or vaccines approved for COVID-19 be promoted to the public?

Life sciences companies often advertise newly-approved drug to the public. But as companies seek approval for products to treat or prevent COVID-19, an extraordinary amount of public interest in those products may require a different commercial and regulatory approach on the part of sponsors. AgencyIQ explains.   By Lily Rosenfield and Alexander Gaffney, RAC The …

How should drugs or vaccines approved for COVID-19 be promoted to the public? Read More »

IQ Explainer: How the FDA does (and doesn’t) regulate serological tests for COVID-19

Serological testing for COVID-19 is intended to identify individuals already exposed to—and potentially immune to reinfection from—the virus. However, the FDA’s approach to regulating the tests has resulted in inconsistent oversight. AgencyIQ explains the FDA’s current approach, current issues, and potential paths forward.   By Laura DiAngelo, MPH Serological tests are those that can detect …

IQ Explainer: How the FDA does (and doesn’t) regulate serological tests for COVID-19 Read More »

COVID-19 could disrupt how companies and FDA track drug safety

The way in which the FDA and life sciences industry track adverse events associated with drug products could be disrupted by COVID-19. AgencyIQ explores how this might occur and what it could mean for the industry.   By Kedest Tadesse, MS, RAC and Alexander Gaffney, RAC As the life sciences industry and FDA work to …

COVID-19 could disrupt how companies and FDA track drug safety Read More »

FDA issues guidance facilitating broader access to pathology devices

Producers of remote digital pathology devices, which allow for the review of patient images, will be temporarily exempted from most regulatory requirements by the FDA in a development intended to help allow health care workers to reduce their exposure to patients with COVID-19. By Laura DiAngelo, MPH How Things Work Now Medical devices are typically …

FDA issues guidance facilitating broader access to pathology devices Read More »

Public interest in development of COVID-19 drugs presents regulatory challenges for companies

There is an extraordinary amount of public interest in the development of drugs, biologics and vaccines for COVID-19. But just as companies are trying to generate evidence about the safety or efficacy of their products, that same public interest threatens to hurt their ability to collect it—and may even trigger scrutiny by regulators.   By …

Public interest in development of COVID-19 drugs presents regulatory challenges for companies Read More »

COVID-19 could lead to disruptions in the availability of generic drugs in the US

As COVID-19’s effects have begun to spread across the globe, it is raising concerns about the potential to cause major disruptions to the availability of generic drugs in the United States.   By Kedest Tadesse, MS, RAC Many generic drugs are made outside of the United States. The FDA’s Center for Drug Evaluation and Research …

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Generic drug approvals appear mostly unaffected by COVID-19, but broader impacts may soon be seen

FDA operations have been disrupted by the COVID-19 outbreak. But according to a review of FDA data on generic drug approvals from Q1, the agency has not yet seen any meaningful impact on generic approvals.   By Lily Rosenfield How things work now The FDA approves generic drugs through a regulatory pathway known as an …

Generic drug approvals appear mostly unaffected by COVID-19, but broader impacts may soon be seen Read More »

A record number of Emergency Use Authorizations pose a challenge for FDA: How to remove them effectively

As it works to confront COVID-19, the FDA has been approving a record number of Emergency Use Authorization (EUA) requests for diagnostics, medical devices and drug products.   But as the FDA published a record number of authorizations, it will soon need to grapple with the exact opposite problem: How to remove record numbers of …

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FDA changes policy to permit more extensive compounding of drugs to treat COVID-19 patients

The regulator says it does not plan to object to certain facilities generally regulated by state boards of pharmacy making copies of certain painkillers and muscle relaxants used to treat patients with COVID-19.   By Alec Gaffney  How things work now The FDA defines drug compounding as the practice of a licensed professional combining, mixing or altering …

FDA changes policy to permit more extensive compounding of drugs to treat COVID-19 patients Read More »

To further aid health worker distancing, the FDA allows increased use of remote health devices

  Producers of telethermographic systems and digital health devices cleared for the treatment of behavioral and psychiatric disorders will be temporarily exempted from most regulatory requirements by the FDA. The move is intended to help support healthcare workers and patients during the COVID-19 emergency.   By Laura DiAngelo, MPH    How Things Work Now Medical …

To further aid health worker distancing, the FDA allows increased use of remote health devices Read More »

Beyond FDA approval: The next big hurdle for COVID-19 drug and vaccine development could be scale

While the FDA has stated they will work to approve or authorize new products to address COVID-19 as quickly as possible, approval is not the only barrier companies need to consider. Companies are already grappling with the need to scale up the production of experimental treatments faster than ever, and need to consider the regulatory …

Beyond FDA approval: The next big hurdle for COVID-19 drug and vaccine development could be scale Read More »

FDA aims to alleviate emerging shortages of key painkillers and muscle relaxants

In a major expansion of its temporary policy on compounding, the FDA has announced it will permit outsourcing facilities working with hospitals to compound a substantially larger number of drug products to deal with emerging shortages of essential products used to treat patients with COVID-19.   To contact the author and editor of this analysis, …

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As FDA looks to accelerate drug approvals for COVID-19, it may leverage postmarketing studies to confirm benefits and risks

The FDA has said it wants to review new drugs and biologics intended to treat or cure COVID-19 as quickly as possible. If the agency is willing to review products based on less data, it may wish to use postmarketing studies to confirm the safety and efficacy of those drugs. Here’s what companies need to …

As FDA looks to accelerate drug approvals for COVID-19, it may leverage postmarketing studies to confirm benefits and risks Read More »

Could real-world evidence help to accelerate drug and device testing for COVID-19?

As companies seek to begin testing medical products to treat, cure or prevent COVID-19, they are seeking to collect clinical evidence faster than ever before. While Real-World Evidence could help to expedite the collection of evidence, there are several major impediments to the collection of high-quality data. AgencyIQ explains the promise of—and hurdles to—RWE for …

Could real-world evidence help to accelerate drug and device testing for COVID-19? Read More »

FDA offers roadmap for companies hoping to develop generics of chloroquine and hydroxychloroquine

Two final guidance documents published by the FDA help establish the study requirements needed to support the approval of new generic versions of drugs intended to help treat patients with COVID-19. But as an AgencyIQ analysis shows, the impacts of the guidance documents could be limited.   To contact the author of this article, email …

FDA offers roadmap for companies hoping to develop generics of chloroquine and hydroxychloroquine Read More »

FDA’s Real-Time Oncology Review program: A model for accelerating the review of COVID-19 therapies?

The Real-Time Oncology Review pilot program has been used to expedite the approval of some oncology drugs. As AgencyIQ found, it might also be used to accelerate the review of new drugs and biologics intended to treat COVID-19.  To contact the author of this piece, please email Kedest Tadesse (ktadesse@agencyiq.com).To contact the editor of this …

FDA’s Real-Time Oncology Review program: A model for accelerating the review of COVID-19 therapies? Read More »

The basics of Emergency Use Authorizations: Why an ‘authorization’ isn’t the same as ‘approval’

As the FDA works to bring new medical products to market to treat, cure or prevent COVID-19, the agency is increasingly relying on a rarely-used authority known as Emergency Use Authorization. While the end result of an EUA is similar to a product approval, there are essential differences that matter to life sciences companies, physicians and the public. In this article, AgencyIQ explains the basics of the EUA program, its features and its potential limitations.

As therapies for COVID-19 begin testing, the FDA prepares to face a “breakthrough” problem

As an increasing number of companies begin to test drugs and biologics for COVID-19, many will be soon be eligible to receive a regulatory acceleration designation known as “Breakthrough Therapy Designation.” Despite the name, many of these products aren’t breakthroughs and aren’t ultimately approved, indicating the potential for the name of the designation to confuse politicians, the public and the press.

As COVID-19 leads to new supply chain difficulties, the FDA wants more information on shortages

Amid potential shortages of drug products resulting from the COVID-19 outbreak, the FDA issued new guidance updating policy on how and when manufacturers should notify the agency of manufacturing disruptions. To contact the author of this analysis, please email Laura DiAngelo.To contact the editor of this analysis, please email Alec Gaffney. Executive IQ Brief How Things Work …

As COVID-19 leads to new supply chain difficulties, the FDA wants more information on shortages Read More »

The twenty-two regulatory pathways the FDA is likely to leverage to get new COVID-19 therapies to patients

The FDA has more than 50 regulatory pathways available to companies hoping to get a new drug or biologic approved. Here are the 22 that are most likely to be used to help bring new COVID-19 products to patients.   Alexander Gaffney is the author of this piece (agaffney@agencyiq.com)     The life sciences industry …

The twenty-two regulatory pathways the FDA is likely to leverage to get new COVID-19 therapies to patients Read More »

Webinar: The Regulatory Impact of COVID-19 | Apr. 7 at 12:00 pm EST

This webinar, to be hosted on April 7th from 12:00 pm -1:00 pm EST, is designed to address the information needs of regulatory affairs professionals at pharmaceutical, biotechnology, in vitro diagnostic (IVD), and medical device companies, who are on the front lines of combating the unprecedented public health crisis posed by the novel coronavirus. AgencyIQ will assess how regulatory affairs professionals can navigate rapidly-evolving FDA policy and guidance to get products to test for, treat, and vaccinate against COVID-19 to the public.

Pandemics and intellectual property: How the government can impact COVID-19 drug and device development

The US patent landscape seeks to foster growth and innovation—especially in life sciences. But amid a global pandemic, public-private partnerships and government authority can impact an otherwise routine landscape of drug and device development. Here are four laws, regulations and international agreements that have implications for developers in the COVID-19 crisis.

Two pathways could allow patients quicker access to investigational coronavirus therapies

Two federal statutes—one overseen by the FDA and the other not—could help to facilitate more rapid access to investigational medical products meant to treat COVID-19. But as interest in the programs expand, so too will the pressure on regulators and companies to deliver both results and products to patients. There are significant trade-offs to consider.

Seven Regulatory Problems Laid Bare by the Coronavirus

Few things expose regulatory fault lines quite like an international medical emergency. For the Food and Drug Administration, the novel coronavirus (SARS-CoV-2) outbreak has exposed several longstanding regulatory issues that could have the potential to substantially impact how the US is able to effectively respond to not only this outbreak, but future emerging threats.