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CDER spelled out current good manufacturing practices for drug compounders that register as outsourcers in a new draft guidance — and noted when the FDA does not intend to take…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…

Drug imports to the U.S from Canada “will have little or no impact on U.S. drug prices,” and will cause problems for Canadians, according to Canada’s acting Ambassador to the…

The FDA cited a Huntington Beach, Calif., drug manufacturer for four violations at its facility, including a lack of data backups. Source: Drug Industry Daily

The FDA’s warning letters for 2019 once again targeted many familiar GMP failures, such as quality units that either lacked or failed to follow written procedures. Source: Drug Industry Daily

2019 was one of the biggest years on record for pharma mergers and acquisitions, including the third largest acquisition of all time — Bristol-Myers Squibb’s $74 billion acquisition of Celgene.…

The FDA hit Teva with a Form 483 for its handling of complaints and other deficiencies at its facility in Jerusalem, Israel. Source: Drug Industry Daily

Novartis has forged a merger agreement with The Medicines Company under which it will buy up the firm’s cholesterol drug inclisiran for a whopping $9.7 billion. Source: Drug Industry Daily