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. Under the rating system, facilities in areas where cases of COVID-19 are under control can expect to be inspected sooner than facilities in areas where COVID-19 cases are on the rise.
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FDA Issues 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 not aware of any drugs that have been contaminated with SARS-CoV-2, but the guidance provides the agency’s expectations for limiting potential contamination. While the FDA has not yet resumed routine facility inspections, and therefore likely will not actively monitor implementation of the risk assessments (or other suggestions in the guidance), manufacturers should consider the recommendations in the guidance to protect the public health and health of their employees.
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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 change in policy reflects growing concerns over the reliability of antibody tests currently on the market. The policy shift also suggests that manufacturers of medical supplies subject to relaxed enforcement policies during COVID-19 should monitor policy developments to confirm the regulatory status of their products.
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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 systems, and equipment to treat respiratory failure.
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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:
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