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December 13, 2023
The new advisory committee will provide the agency with technical and scientific advice and recommendations on potential treatments for genetic metabolic diseases.
Sanofi has issued a statement expressing its disappointment with FTC’s decision to block an exclusive licensing agreement with Maze Therapeutics for a rare disease drug candidate.
Regulators in the European Union have published the first version a list of critical medicines in the EU to avoid potential shortages.
December 11, 2023
The product is being voluntarily recalled because of powder leakage due to seal integrity issues.
The agency released two guidance documents on the interim policy on compounding using bulk drug substances for both outsourcing and non-outsourcing facilities.
December 04, 2023
The medicines, levetiracetam and clobazam, may a cause life-threatening reaction to patients if not caught and treated quickly.
Novartis has issued a nationwide voluntary recall of two lots of Sandimmune Oral Solution (cyclosporine oral solution, USP), 100 mg/mL because of crystallization issues.
December 03, 2023
The bio/pharmaceutical industry is struggling with the challenge of staffing and training.
December 02, 2023
Eradicating paper-based workflows and standalone solutions operating in isolation provides a good starting point to update quality management processes.
The ICH Q9 revision clarifies QRM implementation for the pharmaceutical industry and expands descriptions of methodology, formality, and risk-based decision making to provide the industry with a solid base from which to build their own QRM programs.