FDA

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 …

Socially distant generic litigation: How COVID could slow FDA approvals Read More »

AgencyIQ International Brief: ICH previews new guidelines; Europe looks to supply chain changes; MHRA on 3D printing

Top stories: ICH welcomes new members and previews upcoming guidelines. European Commission starts consultation on supply chain changes and legislation. India looks to speed access to vaccines with foreign data. MHRA offers a pathway for 3D printed devices for COVID-19. Remdesivir’s global debut underway.   By Alexander Gaffney, MS, RAC and Charles Friend Welcome to …

AgencyIQ International Brief: ICH previews new guidelines; Europe looks to supply chain changes; MHRA on 3D printing Read More »

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 …

3D printing during COVID tests FDA’s policies Read More »

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 inspections at record lows, reflecting impact of COVID-19

FDA data show that the agency conducted far fewer facility inspections in March 2020 than any other month in the last decade, reflecting the extent to which COVID-19 is impacting some routine regulatory activities. By Alexander Gaffney, RAC and Kedest Tadesse, MS, RAC The number of FDA inspections of pharmaceutical and medical device firms plummeted …

FDA inspections at record lows, reflecting impact of COVID-19 Read More »

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 …

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

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

New device shortage requirements, FDA’s evolving stance on diagnostics and more in AgencyIQ recap

Each week, the FDA publishes dozens of new policies, updates and regulations. POLITICO’s AgencyIQ analyzes these fast-moving, complex developments so you don’t have to. The following is a glimpse into what our research and news teams published this week. For more information on how you can become a subscriber of AgencyIQ and view all of …

New device shortage requirements, FDA’s evolving stance on diagnostics and more in AgencyIQ recap Read More »

The Weekly Review

Welcome to The Weekly Review – a timely recap of AgencyIQ’s coverage of major life sciences regulatory trends and the biggest developments at FDA from the past week. It’s been an unsettling few days for much of the US as the realization dawns on many that things are about to become abnormal for a few months. During this uncertain time, we’ve been exploring how COVID-19 will affect FDA systems, processes, and regulatory approvals. We’ve also been covering profound developments related to the VALID Act, FDA’s new diabetes drug development guidance, and companies’ response to shifting drug importation policy.

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.