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Susan Haigney is lead editor of BioPharm International®.
December 15, 2023
The guidance document discusses the impact of clinical pharmacology considerations on peptide drug development.
The US District Court for the District of Massachusetts entered a consent decree of permanent injunction against Pharmasol Corporation for distributing adulterated drugs.
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.
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.