Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Tuesday, April 28, 2020
FDA Provides Updates on Adverse Event Reports and Postmarket Activities Associated with Essure
Today, the U.S. Food and Drug Administration issued a letter to Bayer outlining conditions for submitting additional postmarket information to the agency about Essure—a permanent birth control device Bayer sold in the U.S. until 2018. The letter applies to reportable adverse events Bayer is or becomes aware of from social media information received in relation to ongoing litigation regarding Essure.
Because of the anticipated volume and nature of this information, the FDA granted Bayer’s request for a variance from some medical device reporting requirements but imposed conditions for reporting to ensure protection of the public health. Under the conditions, Bayer is required to ...