The European Medicines Agency issued a draft paper to clarify the responsibilities of marketing authorization holders (MAHs) under the EU’s GMP regulations, which the EMA conceded can be confusing. Source:…
CDER spelled out current good manufacturing practices for drug compounders that register as outsourcers in a new draft guidance — and noted when the FDA does not intend to take…
The FDA released two final guidances yesterday outlining the agency’s approach to drug-drug interaction (DDI) studies for DDIs mediated by cytochrome P450 (CYP) enzymes and transporters. Source: Drug Industry Daily
In a final guidance, the FDA outlined the new structure of the user fee program under the Biosimilar User Fee Act of 2017 (BSUFA II) which eliminated certain fees and…
BTS Research is pleased to share with its clients the results of the FDA audit which was concluded on December 4th, 2019. Following a 14-day onsite inspection, the FDA concluded…
The FDA cited six devicemakers for a range of GMP and other failures, including root-cause analysis for nonconforming products and lax environmental controls. Source: The GMP Letter
The FDA released draft guidance for devicemakers on 510(k) submissions for catheter-based devices intended to treat peripheral vasculature lesions, including suggestions on labeling and performance testing. Source: The GMP Letter
The FDA slapped Henan Kangdi Medical Devices with a warning letter over repeat CGMP failures at its Zhoukou, Henan facility, including a lack of testing. Source: The GMP Letter
The EU’s Medical Device Coordination Group released new guidance on cybersecurity requirements for devicemakers under the new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). Source: The GMP…
The International Organization for Standardization released a new standard to help devicemakers improve their risk management. Source: The GMP Letter