On May 5, 2021, the U.S. Food and Drug Administration (FDA) issued a much-anticipated report, “Resiliency Roadmap for FDA Inspectional Oversight,” which provides a roadmap for the agency’s post-pandemic plans to return to a consistent state of inspection operations. For the near term, FDA reports that it will continue to prioritize critical inspections
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Breaking Down FDA’s New Remote Monitoring Strategy
On Wednesday, April 14, 2021, the US Food and Drug Administration (FDA) published a long-awaited final guidance document explaining its policy for conducting remote “evaluations” during COVID-19. According to the guidance, FDA will request and conduct voluntary remote evaluations at (1) facilities where drugs and biologics are manufactured, processed, packed, or held; (2) facilities covered…
FDA Update: The Latest on Vaccine Development, Inspections, and Conducting Clinical Trials During Covid-19
This week, FDA Commissioner Stephen M. Hahn, M.D., along with Dr. Anthony S. Fauci, M.D., of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, and officials from the Centers for Disease Control and Prevention and U.S. Department of Health and Human Services testified on Capitol Hill on the federal response…
FDA Announces Plans to Resume Domestic On-site Inspections
On July 10, 2020, Commissioner Hahn of the U.S. Food and Drug Administration (FDA) issued a statement announcing that the agency is planning to resume on-site inspections of domestic facilities during the week of July 20. The Agency has developed a “COVID-19 Advisory Level” risk-based rating system to help assess where inspections may safely resume. …
FDA Issue Guidance on Manufacturing Drugs, APIs during COVID-19
FDA issued new guidance on June 19, 2020, advising manufacturers of drugs, biologics, and active pharmaceutical ingredients (APIs) on manufacturing controls to prevent contamination of drugs with SARS-CoV-2, including performing risk assessments to determine whether the virus poses new risks to drug products, or to the manufacturing facilities or processes that produce them. FDA is…
Navigating FDA Policies for PPE, and Liability Protections
The US Food and Drug Administration (FDA) has been developing and shifting its guidelines for Personal Protective Equipment, or PPE, during COVID-19. The Agency has articulated its guidelines for PPE in one of two ways: (1) through guidance documents and (2) through issuance of “umbrella” Emergency Use Authorizations (EUAs) that cover certain product types. EUAs…
Not So Fast – FDA Retracts Authorization for Some Respirators Made in China
Immunity under the Public Readiness and Emergency Preparedness (“PREP”) Act is a moving target for government contractors and other companies manufacturing or distributing personal protective equipment (PPE) in the COVID-19 public health response. We wrote previously about new liability protections afforded to manufacturers and distributors of certain face masks approved by National Institute for Occupational…
FDA Updates Policy to Curb Unreliable COVID-19 Antibody Tests
On May 4, 2020, the US Food and Drug Administration (FDA) updated its enforcement policy on antibody tests for COVID-19. The revised policy requires developers of commercial antibody tests to submit a request for emergency use authorization (EUA) to FDA. Under the previous policy, commercial test developers could distribute their tests without FDA authorization. The…
Upping Hospitals’ Liability Defenses For COVID Measures
This article originally appeared in Law360 on April 13.
The Public Readiness and Emergency Preparedness Act, along with the declaration by the U.S. Department of Health and Human Services on countermeasures against COVID-19, provide hospital systems with broad liability protections for measures taken in response to the pandemic.
There are limitations, however, to immunity under…
April 16 Update: Key FDA Actions for COVID-19 Devices and Therapies
As reported earlier here, FDA is taking steps to increase the availability of Personal Protective Equipment (PPE) and COVID-19 diagnostic tests, support the development of therapeutics, and facilitate remote patient access to healthcare providers. Key FDA regulatory developments since our last update include new Emergency Use Authorizations (EUAs) for face shields, N95 respirator decontamination…
Update: Key FDA Actions for COVID-19 Devices and Therapies
FDA is taking action every day to increase the availability of Personal Protective Equipment (PPE) and COVID-19 diagnostic tests, to support the development of therapeutics, and to facilitate remote patient access to healthcare providers. Recent key FDA developments include:
PPE (Personal Protective Equipment)
- Face Masks, Respirators, Gowns, Gloves. FDA hosted a webinar on April
…
Personal Protective Equipment & Ventilators: How FDA Is Increasing Supply for the US Healthcare System
In light of the widely reported shortage of personal protective equipment (PPE), ventilators, other medical devices, the U.S. Food and Drug Administration (FDA) is working around the clock to authorize medical supplies for the US healthcare system, including relaxing its rules for importing and distributing PPE and ventilators and their accessories (e.g., vent splitters for…
FDA Grants COVID-19 Diagnostic Emergency Use Authorizations, And Other Recent FDA Actions to Address COVID-19
The U.S. Food and Drug Administration (FDA) issued two Emergency Use Authorizations (EUA) for commercially distributed COVID-19 diagnostic tests at the end of last week. The first authorization was issued to Roche Molecular Systems, Inc., for its cobas SARS-CoV-2 Test, and the second issued the following day to Thermo Fisher Scientific, Inc., for its…
FDA Postpones Ex-US Facility Inspections
U.S. Food and Drug Administration (FDA) Commissioner Stephen M. Hahn, M.D., announced that FDA is postponing foreign inspections through April 2020 in response to the COVID-19 outbreak. Manufacturers, including contract manufacturers, anticipating post-approval inspections may welcome the news, given other pressing issues facing ex-US facilities (i.e., facilities located outside the US) in light of COVID-19. …
How FDA is Reacting to the Coronavirus, and 2020 Regulatory Priorities
The nation’s reaction to the Coronavirus Disease (COVID-19) has been fierce—maybe unprecedented. Information so far suggests that most COVID-19 illness is mild, yet the reaction from global markets has been drastic. The US Food and Drug Administration (FDA) is closely monitoring the impact of the Coronavirus on the global drug supply chain and is focused…
FDA Year in Review: A Shifting Regulatory Landscape
The FDA actions that dominated 2019 demonstrated a shifting regulatory landscape for certain product types, such as e-cigarettes, foods and supplements containing cannabidiol (CBD), and digital health / machine learning enabled medical devices. FDA continued to take action to lower drug prices by focusing on approvals of competitive biosimilars and generic drugs, and FDA enforcement…