In the interest of supporting regulatory professionals addressing the unprecedented public health threat posed by COVID-19, AgencyIQ will be sharing all content concerning the virus and its regulatory implications on this page as the situation evolves. To learn about AgencyIQ and see more of our coverage of FDA, please contact us:
COVID-19 Drug and Vaccine Development Tracker
The pharmaceutical and biopharmaceutical industry is engaged in an unprecedented search for products to potentially treat, cure or prevent COVID-19. AgencyIQ has reviewed ClinicalTrials.gov, company announcements and media reports to provide a detailed landscape of the COVID-19 development pipeline.
Latest AgencyIQ COVID-19 Analysis
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
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
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
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
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
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,
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
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
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
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
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
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,
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
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
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
