Sep 21, 2021 | Drug and Device Corner, Drugs, Medical Devices
As part of the 2020 CARES Act, section 506J has been added to the FD&C Act. This section requires manufacturers of certain medical devices to report any interruption or permanent discontinuance in manufacturing to the CDRH. The list of relevant devices can be...
Sep 2, 2021 | Drugs, Seminar
Drug OTC GMPs and Labeling A Five-Part Virtual Series Presented by Bryan Coleman, Senior Director of Pharmaceuticals and Medical Devices; Victoria Pankovich, EAS Regulatory Specialist; Norma Skolnik, EAS Independent Consultant; and Bruce Elsner, EAS Independent...
Sep 1, 2021 | Cosmetics, Did You Know, Dietary Supplements, Drugs, Foods
Color additives for most FDA-regulated products (tobacco and some medical device products are exceptions) must be approved by FDA and listed in the Code of Federal Regulations. If a color additive isn’t listed, its approval must be petitioned and approved by FDA prior...
Aug 23, 2021 | Drug and Device Corner, Drugs, Medical Devices
FDA has announced most FY2022 user fee rates this month, conspicuously missing are the OMUFA 2022 user fee rates. We will continue to monitor Federal Register notices and share information as soon as it becomes available. Federal Register Vol. 86, No. 142 announcing...
Aug 10, 2021 | Drugs, EAS in the News Drugs
EAS independent consultant, Radhika Rajagopalan answers your questions on DMF submissions in Tablets and Capsules magazine. Under the Generic Drug User Fees Act (GDUFA), the FDA applies a holistic, life-cycle approach to the evaluation of active pharmaceutical...
Jul 29, 2021 | Drugs, EAS in the News Drugs
By Amy Scanlin Reprinted with permission from FDLI Update Good Manufacturing Practices—those minimum requirements for methods, facilities, and controls used in manufacturing, processing, and packing of drug products.1 Though clearly articulated by FDA, a review of FY...
