You are here: Industry Insights > MDR

News List

EU’s Medical Device Regulation is now applicable europeanpharmaceuticalreview
May 28, 2021
Europe’s Medical Device Regulation is now applicable to medicines with an integral device, devices containing an ancillary medicinal substance and several other products.
FDA Releases Updated Essure Report americanpharmaceuticalreview
March 22, 2021
The U.S. Food and Drug Administration (FDA) posted the seventh spreadsheet of reportable adverse events that Bayer is required to submit as outlined in the April 24, 2020 variance from MDR reporting requirements.
FDA Posts Additional Postmarket Information for Essure americanpharmaceuticalreview
August 13, 2020
On April 24, 2020, the FDA granted, in part, Bayer’s request for a variance from some medical device reporting requirements subject to the conditions outlined in a letter issued to Bayer.
FDA clears first clinical study for a polymicrobial phage library-based treatment for antibiotic-resistant infections pharmaceutical-business-review
March 17, 2020
Adaptive Phage Therapeutics (APT) said that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for the clinical development of PhageBank.
Multidrug-Resistant Salmonella Outbreak Characterized drugs
August 23, 2019
A recent multidrug-resistant (MDR) Salmonella enterica serotype Newport outbreak, affecting patients in 32 states, was associated with soft cheese and beef consumption...