Jul 1, 2020 | Drug and Device Corner
OTC Monograph reform is here. The FDA recently distributed an email to all drug establishments registered as OTC manufacturers in preparation for the Over-The-Counter Monograph User Fee Program (OMUFA). OTC Monograph Reform legislation passed by congress this spring...
Jun 1, 2020 | Drug and Device Corner
FDA anticipates that during a pandemic, industry and FDA workforces may be reduced because of high employee absenteeism while reporting of adverse events related to widespread use of medical products indicated for the treatment or prevention of the pathogen causing the pandemic may increase. The extent …
May 1, 2020 | Drug and Device Corner, Drugs, Medical Devices
On 1 April 2020, FDA Requests Removal of All Ranitidine Products from the Market immediately, for both prescription and OTC drugs. This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications....
Apr 1, 2020 | Drug and Device Corner, Drugs, Medical Devices
Please see the end of our monthly segment for COVID-19 specific information. The FDA issued a requirement for a stronger boxed warning about serious mental health side effects for the asthma and allergy drug montelukast. The FDA took this action after a review of...
Mar 1, 2020 | Drug and Device Corner, Drugs, Medical Devices
The FDA has published a revision to Manual of Policies and Procedures 5240.3, Prioritization of the Review of Original ANDAs, Amendments, and Supplements. This update is designed to efficiently allocate limited agency resources to areas where priority review is most...
Feb 1, 2020 | Drug and Device Corner, Drugs, Medical Devices
Is your labeler code up to date?!? Chances are if you have not thought about this file since you originally requested a labeler code from the FDA, it could use an update. We saw during the drug listing certification period, that several labeler codes were reflecting...
