Clearly, the COVID-19 pandemic has had an impact on clinical studies during drug development, and that includes in vivo bioequivalence studies. The FDA has reacted to the potential issues it sees by issuing a statement entitled Bioequivalence Studies for Submission in ANDAs during the COVID-19 Pandemic (here). In discussing the types of challenges that may […]
Propofol is an excellent anesthetic, relatively safe with a fast induction time and relatively quick recovery time. It is used in all types of surgical and non-surgical procedures (including intubation and time on a vent if the patient is in distress). With all the COVID 19 cases and the resultant hospitalizations and ICU stays, the […]
In a post entitled The Path Forward: Coronavirus Treatment Acceleration Program (here) penned by FDA Commissioner Steven Hahn, CBER M.D., Director Peter Marks, M.D., Ph.D., and CDER Director Janet Woodcock, M.D., the FDA describes the accelerated actions the Agency is taking to move the most promising therapeutic treatments to patients as quickly as possible. Just […]
Through April 19 (and one action for the 20th) reporting on the FDA all Approvals list (here) tallies 37 full approval actions and 16 tentative approval actions for a total of 53 approval actions. The month started out very strong and, if the rate of approvals continues through the end of the month, OGD might […]
CBD products are available just about everywhere – you see them show up in gas stations, supermarkets, the internet, convenience stores, farm markets, and just about any place where things are sold. CBD appears in drinks, pastry, candy, as an oil, and is infused in just about anything that can be orally ingested, or in […]
Early on Monday morning April 20, 2020, the FDA announced a relaxed policy for pharmacy compounders, if there is a shortage of certain drug products to treat COVID-19 patients that are not available through the normal supply chain or from a registered outsourcing facility. The guidance, titled Temporary Policy for Compounding of Certain Drugs for […]
FDA released Revision 1 to its November 12, 2015 Manual of Policy and Procedures (MAPP) 5200.7 which contains “minor clarifications and formatting”, and added Attachment 2 – Work Guide for Prior Approval Supplements: Requirements for a Filing Review. Just a reminder that a MAPP is a document that provides a transparent view into how the […]
The FDA posted a notice indicating that they continue “to investigate the presence of the N-Nitrosodimethylamine (NDMA) impurity in ranitidine and is now aware of NDMA in nizatidine, which is chemically similar to ranitidine.“ They have found levels on NDMA in one company’s product that exceed the accepted limits and that company has initiated recall […]
Yesterday was day one of the 2-day Generic Drug Forum presented virtually by the Agency in conjunction with the CDER Small Business and Industry Assistance program. There were many sessions which are all available here, including presentations on product-specific guidances, OGD labeling review and requirements, new program requirements under FDARA, pre-ANDA interactions with FDA, electronic […]
On the Federal Register prepublication page (here), the FDA gives notice of the finalization of two guidance documents providing bioequivalence recommendations for two drug products that have received a lot of recent news attention, chloroquine phosphate and hydroxychloroquine sulfate. The two products have received attention because of the COVID-19 pandemic and the anecdotal reports of […]
