While the Biden administration and US Congress continue to debate ways to address perceived prescription drug pricing concerns, the Food and Drug Administration (FDA) is taking action. Under its Drug Competition Action Plan (DCAP), administered by the Office of Generic Drugs (OGD), FDA has published approximately 24 guidance documents since 2017, directing industry stakeholders on how to develop, prepare, and submit abbreviated new drug applications (ANDAs), so that generic drugs can obtain timely FDA approval and more quickly reach the market. In January 2022, FDA published three more guidance documents in the DCAP series.
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The US Food and Drug Administration (FDA) has issued new guidance describing its current recommendations with respect to master protocols for the evaluation of drugs and biologics to treat or prevent COVID-19. While somewhat belated, this guidance may shed light on FDA’s approach to master protocols for other disease states/products.
Morgan Lewis FDA, litigation, and healthcare lawyers authored a LawFlash outlining key issues that companies marketing products and services for coronavirus (COVID-19) should be aware of, including healthcare, FDA, clinical laboratory, product liability, and digital and telehealth laws and regulations.
Morgan Lewis FDA lawyers authored a LawFlash on June 29 summarizing FDA’s drug and biologic coronavirus (COVID-19) guidances to date.
The need for alternative sources of alcohol for hand sanitizer products continues to grow in response to the coronavirus (COVID-19) pandemic. Following its March 20 guidance, which allowed companies not previously registered to produce over-the-counter hand sanitizer to do so, the FDA released additional guidance on what conditions should be met for the manufacture of alcohol for hand sanitizer products. Kathleen Sanzo, Jacqueline Berman, and Alexandre Gapihan itemize those conditions in their recently authored LawFlash.
In its March 20 guidance, FDA addresses postmarket adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic. Kathleen Sanzo, Jacqueline Berman, Michele Buenafe, and Dennis Gucciardo explain the guidance in this LawFlash.
Through FDA’s Policy for Certain REMS Requirements During COVID-19 Public Health Emergency, FDA provides temporary relief from laboratory testing and imaging requirements for certain drugs and biologics subject to REMS with those specific prerequisites.
In light of the growing coronavirus (COVID-19) public health challenge, the FDA issued guidance on March 18 on general considerations for conducting clinical trials of medical products during the COVID-19 pandemic.
The FDA issued guidance on March 20 for the manufacture of hand sanitizers by companies not previously registered to make OTC drugs.
The FDA announced on March 18 that it is suspending onsite routine domestic inspections in an effort to slow the spread of the coronavirus (COVID-19) and help flatten the pandemic curve.