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Manufacturing

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Biotech Firms Struggle To Replicate Analytical Methods For Commercial Use

The process of transferring analytical methods from research labs to commercial labs is fraught with challenges and biotech manufacturers must pay careful attention to everything in the transfer process, especially for overseas transfers. A diverse toolkit is needed to test these complex molecules. An increasing number of product launches is putting pressure on biotech manufacturers to complete these tech transfers quickly, and industry is receiving little guidance from FDA.

Biologics Manufacturing Quality
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Latest From Manufacturing

FDA Urges Full Participation In Quality Metrics Program

Despite the voluntary nature of US FDA’s program, an agency official urges full participation. Without data from such participation, FDA will not be able to predict drug shortages and industry will not see the benefits of reduced inspections and streamlined change control.

Manufacturing Quality

Pfizer Warning Letter Trips Up Sandoz/Momenta’s Expected Glatopa Launch

Sandoz/Momenta’s generic of Teva’s 40 mg Copaxone appeared imminent – until apparently unrelated FDA warning letter regarding contract manufacturer Pfizer’s McPherson, Kan., plant put review on hold.

Manufacturing Quality

Quality Regulatory Updates In Brief: ICH, EMA, MHRA and FDA

ICH updates progress made on quality guidelines; EMA talks combination products; UK MHRA report sheds light on GMP deficiencies; MHRA official describes compliance escalation; FDA guides microbiology reviewers through Common Technical Document; FDA OKs reliance on non-USP compendia in applications.

Quality Manufacturing

A Drag On Drugs? Trump’s Tariffs Could Raise Costs, Particularly For Generics

Drug makers remain mum on Trump tariffs despite worries that older generics could get squeezed. Landmark WHO study is adamant that tariffs should never be imposed on medicines.

Manufacturing Policy

How US Tax Plan Could Affect Global Pharma Manufacturing Networks

Allergan, Pfizer, Bristol-Myers Squibb, AbbVie, GSK, Sanofi and Roche showed glimpses in recent earnings calls of potential impacts on their global manufacturing networks from a US plan to legislate border-adjusted tax cuts. But there was not a word about President Trump’s threat of tariffs.

Manufacturing Policy

US FDA's Drug Shortage Effort Questioned By GAO

GAO's 'high risk' report lowers FDA grade for its drug shortage action plans, saying efforts have not been sustained.

FDA Life Cycle Management
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