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Irradiation Regulation Repeal to Help OTC Drugs

[ Price : $8.95]

Federal Register notice: FDA issues a final rule to repeal a regulation that required an FDA-approved NDA or ANDA for any drug pro...

Boston Scientific Disposable Duodenoscope Cleared

[ Price : $8.95]

FDA clears a Boston Scientific 510(k) for its Exalt Model D Single-Use Duodenoscope.

Draft Guide on Drug Development Tools Qualification

[ Price : $8.95]

FDA releases a draft guidance on Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff.

Final Rule on Device e-Submissions

[ Price : $8.95]

Federal Register notice: FDA issues a final rule amending requirements for medical device premarket submissions to require a singl...

Draft Guide on Pediatric Oncology Drugs

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Federal Register: FDA makes available a draft guidance entitled FDARA Implementation Guidance for Pediatric Studies of Molecularly...

Futura to Seek FDA Placebo Pathway for ED

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Futura Medical says it intends to discuss with FDA a medical device regulatory approval pathway for the placebo arm from an erecti...

Industy Reps Sought for Mammography Panel

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Federal Register notice: FDA seeks industry organizations interested in participating in selecting nonvoting industry representati...

FDA Qualifies MRI Compatibility, Safety Software

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FDA qualifies the first computational modeling tool to be used with a wide range of implantable active medical devices through the...

Seven Observations on Exela FDA-483

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FDA releases an FDA-483 with seven observations from an inspection at the Exela Pharma Sciences outsourcing facility.

Webinar on FDA-3542 and FDA-3542a Updates

[ Price : $8.95]

A CDER Webinar explains updates to forms FDA-3542a and 3542 and instructs participants on how to complete the forms.