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June 15, 2017
A consent decree of permanent injunction was entered between the United States and the two companies due to unapproved, mislabeled, and adulterated drugs.
June 14, 2017
The agency sent a warning letter to A-S Medication Solutions LLC after it found the company didn’t comply with drug listing file requirements.
FDA Commissioner Scott Gottlieb announced the July meeting as part of his commitment to address opioid abuse.
FDA sent a warning letter to drug compounder DCA, Inc. dba Beacon Prescriptions for failing to ensure sanitary conditions.
June 08, 2017
FDA asked Endo Pharmaceuticals to remove Opana ER from the market, citing the potential for abuse.
June 06, 2017
Yusef Manufacturing Laboratories, LLC received an FDA warning letter citing CGMP violations at its Clearfield, UT facility.
May 23, 2017
CBER is moving forward with the development and approval of regenerative medicine advanced therapies.
FDA cited the facility for violations of quality management and data integrity CGMPs.
FDA’s new commissioner asks staff for suggestions for fighting the opioid crisis.
May 22, 2017
The agency is warning drug manufacturers about Burkholderia cepacia complex after product recalls due to contamination.