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April 15, 2016
The agency published draft guidance on prescription requirements, hospital pharmacies, and outsourcing facilities for compounders.
April 12, 2016
The agency issues safety guidance to minimize medication errors relating to product design and container closure design.
April 08, 2016
The FDA guidance describes information to provide to the agency when submitting a proposed proprietary name.
April 02, 2016
A global API marketplace increases the burden of supply chain monitoring for drug companies.
The authors discuss the concept design of a versatile, sustainable, small-scale facility in Malta that conforms to the European Union’s current good manufacturing practices.
April 01, 2016
The draft guidance states information concerning a clinical study of a biosimilar should only be included if it is necessary to demonstrate the safety and efficacy of the drug.
Pharma has huge responsibilities resting on its shoulders to deliver safe and effective medicine.
March 29, 2016
The report examines the increased number of companies cited by regulators for data integrity issues.
March 25, 2016
The draft guidance outlines ways applicants can test for abuse deterrence in solid oral opioid drugs.
March 16, 2016
Revised versions of ISO 14644 adopt changes to sampling procedures and monitoring plans for cleanrooms.