Latest Federal Register Notices
More Product-specific Bioequivalence Guides
05/20/2022 Federal Register notice: FDA has made available additional draft and revised draft product-specific guidances. The documents provide product-specific recommendations on, among other things, bioequivalence study design to support ANDA submissions. To view the notice, click here.
Science Board to Discuss Cannabinoids, Animal Studies
05/18/2022 Federal Register notice: FDA has announced a 6/14 Science Board to the Food and Drug Administration Advisory Committee meeting. Panel members will consider challenges in evaluating the safety of dietary supplement and food ingredients with predicted pharmacological activity, utilizing cannabinoids as a case study. They will also hear about the agency’s enhanced efforts to spur the development, qualification, and adoption of new alternative methods for regulatory use that can replace, reduce, and refine animal testing. To view the notice, click here.
Guide on Container Labeling Safety Considerations
05/17/2022 Federal Register notice: FDA has made available a final guidance entitled “Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors.” The document provides a set of principles and recommendations for ensuring that critical elements of a product’s container label and carton labeling are designed to promote safe dispensing, administration and product use. It is also intended to improve the container label and carton labeling to minimize medication errors, and includes examples of labeling designs that resulted in postmarketing medication errors. To view the notice, click here.
Howard Head Debarred for 5 Years
05/16/2022 Federal Register notice: FDA is debarring for five years Howard Stanley Head from importing or offering for import any drug into the U.S. In 11/2021, Head was convicted of conspiracy to import misbranded prescription drugs, under his business “Dr. Head’s Meds.” To view the notice, click here.
HIV Tests Down Classified to 510(k)
05/13/2022 Federal Register notice: FDA is issuing a final order to reclassify certain human immunodeficiency virus (HIV) serological diagnostic and supplemental tests and HIV nucleic acid diagnostic and supplemental tests, which are postamendments Class 3 devices with the product code MZF, into Class 2 (special controls), subject to premarket notification. The reclassification will reduce the regulatory burdens associated with these device types, as manufacturers will no longer be required to submit a PMA and instead now can submit a 510(k). To view the notice, click here.