COVID-19

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 …

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

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 …

FDA provides further clarity on clinical trial adverse event reporting Read More »

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 »

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 …

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

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 »

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 »

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 »

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 »

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 »

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 »

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 …

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

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 …

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

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 »

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 »

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 …

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

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 »

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 »

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 »

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 »

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 »

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 …

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

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 »

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 …

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

Due to COVID-19, the FDA’s ordinary operations are being disrupted. But based on a review of Q1 data by AgencyIQ, there has not been a disruption in the number of new drugs approved—yet. By Lily Rosenfield  How Things Work Now Once a pharmaceutical company submits a new drug to the FDA for its review, the …

FDA new drug approvals unfazed by COVID-19 – so far Read More »

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 »

  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 »

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 »

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, …

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

The FDA and US life sciences industry are moving at breakneck speed to try to bring new treatments, cures and vaccines to market for COVID-19. But even as regulatory hurdles are cleared or lowered, there are many challenges ahead for both the FDA and industry. In this analysis, AgencyIQ looks at four challenges the FDA …

Four emerging challenges to the FDA posed by COVID-19 Read More »

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 »

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 »

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 »

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 »

Four new FDA guidance documents aim to make certain devices used to treat or detect COVID-19 more readily available. The changes will allow companies to market their devices more easily without needing to seek approval or clearance for certain changes.

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 companies rush to get treatments for COVID-19 into clinical testing, they could benefit by working together to implement something called a “master protocol.” Here’s how that would work.

US blood supply policy is notoriously stringent, placing significant limits on who can donate blood. However, with the ongoing COVID-19 pandemic, the FDA is allowing new individuals to donate blood.

The FDA has announced it is postponing most foreign and all domestic inspections of facilities. While the move will have an impact on FDA’s ability to oversee the production of approved drugs, it may also limit the FDA’s to approve new products as well. AgencyIQ explains how.

A 1983 law known as the Orphan Drug Act was intended to be used to incentivize the development of drugs for rare diseases. So how did a drug for COVID-19 get a package of special incentives? AgencyIQ unpacks the history, regulations and context behind the drug remdesivir, an antiviral currently in clinical trials for treating COVID-19.

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.

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 »

Compounders have gotten the all-clear to make hydroxychloroquine sulfate and chloroquine phosphate using bulk chemicals, a move intended to address emerging shortages of the drugs during the COVID-19 pandemic.

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 »

New guidance from the FDA will permit greater production and distribution of personal protective equipment by non-healthcare companies. The policy could help alleviate a shortage of the essential equipment needed to respond to COVID-19.

New FDA policies to permit reprocessing respiratory equipment and allowing unapproved or uncleared devices on the market represent a changing dynamic under the agency’s traditionally risk-averse framework.

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.

As the FDA prepares to review drugs and biologics intended to treat, cure or prevent COVID-19, it will soon need to decide whether to make use of its advisory committees to help it review new medical products. While there are benefits to the system, they could slow down reviews at a time when speed is …

Does the FDA need a COVID-19 Advisory Committee? Read More »

The $2.2 trillion Coronavirus Aid, Relies and Economic Security (CARES) Act contains several regulatory provisions important to FDA-regulated industries. AgencyIQ explains these provisions and their potential impact.

A new policy from the FDA aims to expedite the use of “convalescent plasma” to help treat patients affected by COVID-19. But as AgencyIQ explains, there are still rigorous requirements that could limit the use of the therapy for large numbers of patients.

As the White House reports that car and technology companies have been given the go-ahead to begin manufacturing complex medical devices like ventilators, the FDA issues new guidance on what those companies would have to do to start manufacturing.

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.

After a slow start, the FDA is furiously trying to respond to a disease outbreak with every tool at its disposal. But will it be enough?

The FDA is offering life sciences companies additional flexibility to report adverse events about their products as the industry grapples with the effects of the novel coronavirus and its impact on the availability of their staff. Here’s what companies need to know about reporting in the time of COVID-19.

Following reports that alcohol-based hand sanitizer is increasingly difficult to find, the FDA says it will temporarily allow other manufacturing entities—including distilleries—to make hand sanitizer.

The outbreak of the novel coronavirus has increased scrutiny of how diagnostic devices are regulated in the US. Two new legislative proposals would enact very different reforms. AgencyIQ explains what’s at stake and how the proposals would work.

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.

As COVID-19 continues to affect the agency, several advisory committee meetings have been postponed or cancelled. As AgencyIQ’s analysis indicates, while the impact on a small number of products could be large, advisory committees are not used as often as they once were, mitigating the broader impacts of the cancellations.

Industry experts told AgencyIQ that ongoing clinical trials, as well as trials that were set to begin enrollment, could be hit hard by ripple effects from the novel coronavirus outbreak. Both industry and the FDA are quickly trying to determine how to adapt trials, protect patients, and save the clinical data needed to support future regulatory decision-making.

Companies are racing to develop treatments and vaccines for COVID. But first, they’ll need to figure out how to test the safety and efficacy of these drugs. Here’s what they might be thinking about in the weeks ahead.

Join the AgencyIQ research team for a conference call on Wednesday, March 25th at 3:00 pm EST for a conference call to discuss the regulatory impact of COVID-19.

An updated policy from the FDA will permit states to validate and oversee the development and distribution of tests to detect COVID-19 without first receiving approval from the FDA, and manufacturers to begin using certain tests before obtaining FDA approval. The extraordinary policy reflects considerable urgency to increase testing capacity in the US in the face of a mounting crisis.

An updated policy from the FDA will permit states to validate and oversee the development and distribution of tests to detect COVID-19 without first receiving approval from the FDA, and manufacturers to begin using certain tests before obtaining FDA approval. The extraordinary policy reflects considerable urgency to increase testing capacity in the US in the face of a mounting crisis.

Amidst reports that alcohol-based hand sanitizer is increasingly difficult to find, the FDA says it will temporarily allow compounding pharmacies to make and sell the products. The change in policy follows concerns that people were making their own ineffective versions of hand sanitizer.

The Declaration limits liability for manufacturers developing products to diagnose, treat, mitigate, or prevent the novel coronavirus.

A new bill by Representative Hakeem Jeffries (D-NY) would add the novel coronavirus to the list of diseases eligible to receive a special incentive known as a Priority Review Voucher.

The Food and Drug Administration is suspending in-person meetings, non-essential travel and many external meetings, according to agency communications shared with AgencyIQ.