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July 17, 2019
MHRA has issued a drug alert for the Emerade adrenaline auto-injector device, as a result of the device’s potential to fail in delivery of the dose due to blockage of the needle.
cGMP deficiencies prompted FDA to withdraw approval for 31 Apotex ANDAs
Altaire is voluntarily recalling ophthalmic products because of concerns regarding quality assurance controls in the manufacturing facility.
FDA sent a warning letter to Ecometics, Inc. after the agency found CGMP violations at the company’s Norwalk facility.
July 12, 2019
Slovakia becomes the final European Union country to be recognized by FDA, and the mutual recognition agreement for inspections of manufacturing sites between the US and the EU is now fully implemented.
July 11, 2019
The new guidance offers information for new drug application and biologics license application sponsors regarding population pharmacokinetic analysis.
July 10, 2019
Patient consent is potentially tricky for pharma R&D to navigate as a result of new data protection rules in Europe.
The FDA guidance defines changes to approved risk evaluation and mitigation strategies and clarifies submission guidelines.
The draft guidance provides industry with a guide for using the database to assist in the development of drug products.
FDA released draft guidance on using the USP pending monograph process in the drug application process.