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YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS
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.
Our FDA lawyers discuss provisions in the Coronavirus Aid, Relief, and Economic Security (CARES) Act that are of particular concern and interest for the pharmaceutical, medical device, animal drug, and food industries, as well the potential effects of the stimulus package, in this recent 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.
With the increasing numbers of coronavirus (COVID-19) cases and the declaration of a global pandemic by the World Health Organization, the pharmaceutical and biotech industries are assessing how this situation may impact business operations.
The US Nuclear Regulatory Commission (NRC) and state agencies oversee the possession and use of radiopharmaceuticals and medical devices containing radioisotopes. In this regard, the NRC recently issued two information notices in response to medical events arising from the administration of radiopharmaceuticals.
FDA issued a draft guidance, Demonstrating Substantial Evidence of Effectiveness for Human Drugs and Biological Products (Draft Guidance), on December 19, 2019, as an expansion of its 1998 guidance, Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products (1998 Guidance).