Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.
The FDA issued a warning letter to Ami Cosmetics in Soeul, South Korea, saying the over-the-counter drugmaker had contradictory information in its labeling and its electronic listing in the FDA’s National Drug Code directory. Read More
The FDA hit Eau Zone Huiles Et Fragrances with a Form 483 after an inspection determined the OTC manufacturer had numerous deficiencies at its Montreal, Quebec facility, including cleaning, testing and drug storage issues. Read More
The FDA has cut the amount of time it takes to issue post-inspection classification letters nearly in half over the past three years, according to one of the agency’s top inspection officials. Read More
The EMA noted a steep decrease in GMP inspections in its annual report for 2017, as well as a hike in inspections for good clinical practices and nearly double the amount of pharmacovigilance inspections than the previous year. Read More