The US FDA has asked Braeburn Pharmaceuticals for more information regarding its sustained-release subcutaneous buprenorphine injection in a complete response letter (CRL).
The EMA and US FDA say they agree on how pharmaceutical firms should include quality-by-design (QbD) elements in drug approval and manufacturing change applications, citing a recently completed pilot collaboration.
The process of sorting out problems with the US FDA's controversial Inactive Ingredients Database (IID) is shaping up to be a huge task, particularly as the agency is working through a backlog of missing updates extending back several years.
The Chinese State Food and Drug Administration (SFDA) has revealed
plans to tighten the drug registration review process as it
attempts to improve standards in the nation.
Fine chemicals company Hovione has passed an inspection by the US
Food and Drug Administration (FDA) at its active pharmaceutical
ingredient (API) manufacturing site in Loures, Portugal, as it
tries to conform with ever-stricter standards.
