Drug and Device Corner September 2020
EAS would like to remind all eNews readers of the importance of an appointed U.S. Agent. The FDA recently deactivated the FDA registrations of 340 foreign establishments that failed to identify a U.S. Agent as required by FDA’s regulations. As we head into the FDA...
Drug and Device Corner August 2020
The FDA recently published a laboratory testing method to assess the quality of finished hand sanitizer products. This testing method can be used to help assure hand sanitizers contain the correct ingredients and do not contain harmful levels of impurities. Due to the...
Drug and Device Corner July 2020
The FDA is remaining vigilant in their monitoring of OTC hand sanitizer products. Their highest concerns, from a manufacturing and marketing perspective, are hand sanitizers that may not contain a sufficient amount of ethyl alcohol or isopropyl alcohol. They are also...
Drug and Device Corner June 2020
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...
Drug and Device Corner for May 2020
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 …