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Sterile Drug Production Issues at Innoveix: FDA

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FDA warns Addison, TX-based Innoveix Pharmaceuticals about producing, packing, and holding sterile compounded drugs in insanitary ...

FDA Discouraging Sanitation Tunnels

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FDA issues an immediately effective guidance intended to discourage the use of so-called sanitation tunnels as a way to prevent or...

FDA Briefing Slams Single Country Drug Data

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A just-released advisory committee briefing document shows FDA putting its foot down on drug sponsors conducting drug development ...

Researchers Studying Injectable Suspensions

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FDA says CDER researchers have developed ways to bridge the gap between in vitro and in vivo assessment of injectable suspensions.

FDA Emphasizing Automation

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FDA acting chief technology officer Sohail Chaudhry says automation will be a big part of the agencys digital transformation effor...

Drug User Fee Info Collection Revision

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Federal Register notice: FDA sends to OMB an information collection revision entitled Prescription Drug User Fee Program.

Info Collection on Device Registration/Listing

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Federal Register notice: FDA seeks comments on an information collection extension entitled Establishment Registration and Device ...

Biogen Sued for Aduhelm Securities Fraud

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An Oklahoma pension fund initiates a securities fraud class action suit against Biogen and its top executives over the controversi...

BIO Recommendations for RWD Guidance

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The Biotechnology Innovation Organization recommends changes to an FDA draft guidance on data standards for real-world data in dru...

FDA Digital Health Technology Guidance

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King & Spaulding attorneys praise an FDA draft guidance on using digital health technologies in clinical investigations.