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The new advisory committee will provide the agency with technical and scientific advice and recommendations on potential treatments for genetic metabolic diseases.

FDA Announces Advisory Committee for Genetic Metabolic Disease Treatments

Feliza Mirasol is the science editor for 

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.

Sanofi to Terminate Rare Disease Drug Licensing Agreement with Maze Therapeutics in Wake of FTC’s Challenge

Regulators in the European Union have published the first version a list of critical medicines in the EU to avoid potential shortages.

List of Critical Medicines Published in EU

The product is being voluntarily recalled because of powder leakage due to seal integrity issues.

InvaGen Pharmaceuticals Recalls Vigabatrin for Oral Solution, USP 500 mg

The agency released two guidance documents on the interim policy on compounding using bulk drug substances for both outsourcing and non-outsourcing facilities.

FDA Releases Compounding Guidance

The medicines, levetiracetam and clobazam, may a cause life-threatening reaction to patients if not caught and treated quickly. 

FDA Warns of Rare but Serious Drug Reaction to Antiseizure Medicines

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.

Novartis Voluntarily Recalls Two Lots of Sandimmune Oral Solution, 100 mg/mL

The bio/pharmaceutical industry is struggling with the challenge of staffing and training.

Training for Operational Excellence

Kari Miller is senior director, Product Management, QMS, IQVIA.

Eradicating paper-based workflows and standalone solutions operating in isolation provides a good starting point to update quality management processes.

Revitalizing Quality Management Processes through Digitalization

Kate Coleman is Principal Quality and Compliance Consultant with Arriello Ireland.

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.

Quality Systems