OR WAIT null SECS
February 27, 2017
FDA plans to initiate its quality metrics program as industry continues to push back.
February 23, 2017
The district court ordered Pick and Pay Inc./Cili Minerals to cease operations after it unlawfully manufactured and distributed unapproved new drugs, misbranded drugs, adulterated dietary supplements, and misbranded dietary supplements.
February 21, 2017
The regulatory agency rejected the medication, citing various issues related to device use.
Momenta’s fill/finish contract manufacturer, Pfizer, was cited in the letter.
February 16, 2017
FDA sent a warning letter to Sato Pharmaceutical Co., Ltd. after inspectors found deviations in the facility’s aseptic processes.
February 15, 2017
The agency sent a warning letter to Resonance Laboratories Pvt. Ltd. after an inspection found possible contamination problems.
February 13, 2017
Drug companies are pushing Congress to action on funding for FDA programs and staff to expedite drug reviews and approvals.
February 02, 2017
The warning letter cited GMP violations for finished drug products.
February 01, 2017
In promising to expedite and simplify the FDA approval process, Donald Trump fails to take account of industry's appreciation of an efficient, rigorous FDA regulatory system.
Pharmco Laboratories received an FDA warning letter for significant violations of CGMP for finished drugs and APIs at its Florida, US facility as well as misbranding of over-the-counter (OTC) acne and sunscreen drug products.