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Set Alert for Manufacturing

Mylan's Manufacturing Maelstrom: Trans-Atlantic Recalls And Personal Citation By Gottlieb

GMP quality, once Mylan's calling card, is now an ongoing problem, forcing product discontinuations and apologies to customers. Firm's valsartan products have European certificate of suitability suspended as Morgantown, W.Va. facility draws US FDA warning letter.
Manufacturing Regulation Enforcement

Latest From Manufacturing

US FDA To Rely On Inspections From More European Countries

The US Food and Drug Administration can now rely on the results of GMP inspections from 20 EU member states after confirming that five more countries have been deemed suitable for inclusion in its mutual recognition agreement with the EU.

Europe US States

Beefed-Up SPC Manufacturing Waiver Gains Traction In European Parliament

A proposal to allow generics firms to manufacture versions of supplementary protection certificate-protected medicines in preparation for EU launch immediately on SPC expiry is making progress through the European parliamentary process, to the delight of the generics industry – and the dismay of originator companies.
Europe Intellectual Property

Gilead False Claims Case: Government Opposes Supreme Court Review But Thinks Suit Should Be Tossed

US Solicitor General says facts lacking on what government knew about alleged product misrepresentations; FDA may be burdened with discovery requests if suit proceeds to discovery and trial.

Legal Issues Manufacturing

Serialization Update: Industry Warns Of “Significant Disruptions” If FDA Bars Use Of GSI Global Numbers Under DSCSA

The pharmaceutical industry has already been using GTIN numbers on product packaging to comply with pending serialization requirements and US FDA’s plan to replace the GTIN with the NDC code is drawing much criticism. 
United States Manufacturing

Pharmaceutical Industry Slams FDA’s Guidance On Drug Substance Post- Approval Changes; Say More Alignment With ICH Needed

Like the fabled Rip Van Winkle, FDA guidance on post-approval changes for drug substances has awakened after a long nap to a changed world. Industry is urging FDA to revise its draft in a way that’s less prescriptive and more in line with the science- and risk-based approaches, outlined in ICH Q8, Q9 and Q12 guidelines, that have emerged in the years after the agency withdrew its BACPAC guidance.

United States Manufacturing

Drug Shortages: Is "Buy American" One Solution?

Moving more manufacturing to the US could help increase supply chain reliability, which could prevent or blunt shortages, an industry representative argues.

Manufacturing Generic Drugs
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