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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.
The FDA issued guidance on March 20 for the manufacture of hand sanitizers by companies not previously registered to make OTC drugs.
In FDA’s latest Director’s Corner podcast, Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER or Center), reflects on the Center’s accomplishments of the past year and priorities for 2019.

The proposed Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 could become law in the near future as the Congressional Budget Office reported that the legislation would not increase the budget deficit. The proposed bill would change the oversight of the commercial marketing of OTC drugs by the FDA and authorize the collection and spending of user fees to cover the cost of expediting FDA’s administrative procedures related to OTC products. Both the Senate and the House have proposed versions of the bill that are largely similar with variances mostly in the length of exclusivity. Therefore, manufacturers can reasonably rely on the major provisions of the bill that are not likely to change.  Manufacturers can start preparing for the proposed revisions by organizing their current OTC product portfolios according to the ingredients’ current monograph status and identifying any ingredients that may be at risk for more immediate FDA action that could impact their regulatory marketing status. 

President Donald Trump announced that, as of September 24, 2018, additional tariffs of 10% were imposed on hundreds of chemical ingredients, many of which are used in the manufacturing of dietary supplements, cosmetics, and over-the-counter (OTC) drug products.