Regulatory Oversight and Compliance

Compounding Overview: Primary Considerations in the Workplace

December 18, 2023

Technical, regulatory, and personnel considerations characterize pharmaceutical compounding.

FDA Issues Guidance on Clinical Pharmacology for Peptide Drugs

December 15, 2023

The guidance document discusses the impact of clinical pharmacology considerations on peptide drug development.

Consent Decree Entered Against Pharmasol

December 15, 2023

The US District Court for the District of Massachusetts entered a consent decree of permanent injunction against Pharmasol Corporation for distributing adulterated drugs.

RoslinCT to Manufacture CRISPR-Based Gene Therapy Casgevy

December 14, 2023

RoslinCT will manufacture Vertex Pharmaceuticals’ CRISPR-based gene therapy, Casgevy, recently approved for treating sickle cell disease and β thalassemia.

FDA Announces Advisory Committee for Genetic Metabolic Disease Treatments

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

December 13, 2023

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.

List of Critical Medicines Published in EU

December 13, 2023

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

FDA Releases Compounding Guidance

December 11, 2023

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

FDA Warns of Rare but Serious Drug Reaction to Antiseizure Medicines

December 04, 2023

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

Revitalizing Quality Management Processes through Digitalization

December 02, 2023

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