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Manufacturing

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China Regulatory Shakeup: Top Regulator Out, Commissioner Reprimanded Amid Vaccine Scandal

Amid aftermath of latest vaccine scandal, top officials including China’s drug reform flagbearer are forced to resign, sending shock waves across the industry.

China Drug Safety Manufacturing
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Stress Test For WHO’s Quality Certificate Scheme In The Americas

A project being run in the Americas will assess the way that the Certificate of a Pharmaceutical Product is used and whether it meets the needs of countries in the region. The move is part of the revision of the World Health Organization’s quality certification scheme.
Quality Regulation

FDA Approving Complex Generics Pre-ANDA Meeting Requests At Higher Rates

Approval rates for complex-drug pre-ANDA meeting requests are climbing. FDA’s hope is that the meetings will hasten approvals of these hard-to-manufacture generics, which could put a dent in US healthcare costs.
United States Manufacturing

The Economics Of Drug Shortages: US FDA Seeks Broad Input

FDA is planning series of stakeholder meetings to identify new approaches to drug shortages, with particular interest in defining “essential” drugs. Agency is also looking outside for expertise, with Boston University’s Rena Conti tapped as advisor.
Manufacturing Regulation

Some Double Bar-Coding Required After November DSCSA Deadline, US FDA Says

As agency offers further guidance on how and when to begin complying with Drug Supply Chain Security Act requirements, one twist is that some packages will need two barcodes, depending on the circumstances.

Distribution Manufacturing

Contract Manufacturers Cautioned On Allure of Novel Cell and Gene Therapies

Contract development and manufacturing organizations are fielding requests from sponsors to ramp up for emerging novel treatment modalities like CAR-T cells and gene therapies but shouldn't "over-invest," consultant advises. Meanwhile, MAb production capacity, already huge, is growing 50% over the next five years to meet surging demand.

Business Strategies Manufacturing

FDA Urges Development Of Generic Alternatives To Bring Down Prices Of Complex Drugs

Given the pressing need for more affordable versions of complex drug products like peptides, liposomes, transdermals and metered dose inhalers, FDA is encouraging generic drug companies to submit more applications for generic alternatives. FDA encourages industry to leverage agency-sponsored research for more advice on how to submit applications that will get approved.
Generic Drugs Quality
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