The quality drive at contract manufacturers

FDA has organized its quality initiative around review, inspection, surveillance, policy and research Two trends stand out in the rapidly changing landscape of pharma and biotech manufacturing today: the whirlwind of mergers, acquisitions and buyouts will not let up anytime […]

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Compliance packaging vendors keep innovating

Fig. 1 AstraZeneca’s Seroquel (top), the 2014 HCPC winner; Lilly’s Strattera (middle); Novartis’ Exforge (bottom) Pharma manufacturers (and their contract packaging providers) who are considering compliance (unit-dose) packaging have three trends to take advantage of: More of the overall healthcare […]

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Preventing and Managing Drug Shortages–PDA Technical Report 68

*Excerpted from PDA Technical Report 68, available at no charge, at http://www.pda.org/scientific-and-regulatory-affairs/ regulatory-resources/drug-shortage. Published with permission of PDA. Copyright © Parenteral Drug Association.   Fig. 1. A risk triage model of patient impact. Unfortunately, drug shortages have become more frequent […]

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