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July 28, 2017
Manufacturers are seeking greater oversight of how providers reimburse for and dispense covered drugs.
July 26, 2017
Weak or faulty quality systems can hurt a company at every stage of a product’s lifecycle.
July 25, 2017
The agency has published a Q&A guidance document related to self-identification of facilities, review of generic drug submissions, and inspections.
FDA sent a warning letter to Sage Products, Inc. regarding CGMP failures involving test methods, sampling, and sterilization procedures.
July 18, 2017
The agency cited the Italian company for aseptic processing failures.
July 12, 2017
The agency sent a warning letter to Vista Pharmaceuticals Limited for CGMP failures related to equipment cleaning and process control.
One day after Ocular Therapeutix sent FDA a detailed response highlighting manufacturing improvements, FDA rejected its application for Dextenza, a new drug designed to alleviate post-operative eye pain.
July 10, 2017
FDA sent a warning letter to Shandong Analysis and Test Center for CGMP violations including data integrity issues and insufficient testing procedures.
July 05, 2017
The agency has pushed back by one year the deadline for compliance with DSCSA serialization requirements.
July 02, 2017
CDER’s Janet Woodcock endorses modern drug manufacturing to ensure access to safe and reliable medicines.