FDA Related News

Medical Devices

B. Braun Recalls Blood Administration Sets

FDA says B. Braun is recalling 43,026 blood administration sets that may leak at the joint between blood filters and tubing.

Animal Drugs

Man Indicted for Illegal Animal Drug

A Puerto Rico federal grand jury indicts an individual on charges relating to shipments of an illegal, adulterated, and misbranded animal drug.

Human Drugs

FDA Initial Steps on CBD Explained

Mintz attorney Joanna Hawana explains FDAs position of regulating cannabis-derived products as shown in recent public announcements.

FDA Denies US WorldMeds Apokyn Petition

Citing time restrictions, FDA denies without comment a US WorldMeds petition asking for specific treatment of any ANDA citing its Apokyn.

Biologics

FDA Orders Fertility Clinic to Cease Manufacturing

FDA orders a fertility clinic in San Juan, Puerto Rico, to cease manufacturing due to significant violations of agency regulations.

Human Drugs

Evofem Biosciences Re-files NDA for Amphora

Evofem Biosciences resubmits its NDA for Amphora (L-lactic acid, citric acid and potassium bitartrate), a multipurpose vaginal pH regulator for preven...

Nurse Sentenced for Insys Fentanyl Kickbacks

The Justice Department says an advance practice nurse who worked in a pain clinic was sentenced to three years of probation for accepting kickbacks fr...

Medical Devices

Former FDA Commissioner Frank Young Dies at 88

Former FDA commissioner Frank Young dies at age 88.

Human Drugs

CGMP Violations at Lohxa LLC

FDA warns Lohxa LLC about CGMP violations in its production of finished pharmaceuticals.

Medical Devices

Device-Related Infections Likely Antibiotic-Resistant: Study

A Center for Disease Control and Prevention report says that healthcare-associated infections resulting from medical devices are more likely to be ant...