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Drug Labeling Child-Resistant Packaging Statements

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FDA publishes a guidance with recommendations to assist companies that want to include child-resistant packaging statements in the...

More FDA Clarity Needed on RWE Studies: Attorney

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Ropes & Gray attorneys Kellie Combs and Sarah Blankstein say companies are not likely to get heavily involved in real-world eviden...

Elaris Pedicle Screw System Cleared

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FDA clears a SpineWelding 510(k) for its Elaris Pedicle Screw System, which is intended to provide immobilization and stabilizatio...

Dem Senators Want AveXis Punished Over Data Manipulation

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A group of U.S. Senate Democrats urge FDA acting commissioner Ned Sharpless to heavily punish AveXis for submitting manipulated da...

Shimadzu Medicals Fluorospeed X1 Cleared

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FDA clears a Shimadzu Medical Systems 510(k) for the Fluorospeed X1 patient side conventional radiographic/fluoroscopic table syst...

Comments Extended on Animal Drug Studies Meeting

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Federal Register notice: FDA extends the comment period on a 7/9 notice about a public meeting alternative clinical trial approach...

Public Meeting Seeks Input to Improve CDER Reviews

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Federal Register notice: FDA announces an 11/7 public meeting entitled Promoting Effective Drug Development Programs: Opportunitie...

Levitra Not Withdrawn Over Safety/Efficacy: FDA

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Federal Register notice: FDA determines that Bayers Levitra (vardenafil hydrochloride) tablets, 2.5mg, were not withdrawn from sal...

FDA Warning on Miracle Mineral Solution

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FDA issues a warning against Miracle Mineral Solution because it is illegally promoted as a remedy for treating autism, cancer, HI...

Dare Bio Advancing Bacterial Vaginosis Therapy

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FDA grants Dare Bioscience a qualified infectious disease product designation for its bacterial vaginosis therapy.