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FDA publishes manual on complex product classification for generic development | Snell & Wilmer

The US Food and Drug Administration (FDA) recently published a manual of policies and procedures (MAPP) outlining how the Office of Generic Drugs (OGD) will classify which new drugs and.

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FDAnews Announces Generic Drug Submissions Under GDUFA III: Preparing for FDA s New Five-Year Plan Management Report

Falls Church, VA (PRWEB) April 12, 2022 Generic Drug Submissions Under GDUFA III: Preparing for FDA’s New Five-Year

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POINT Biopharma Reports Fiscal 2021 Financial Results and

Reported 27-patient dosimetry data from the lead-in cohort of the SPLASH trial Randomization phase of SPLASH trial ongoing, top line data expected.

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FDA Approves First Generic of Symbicort to Treat Asthma and COPD

Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines

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FDA approves first generic Symbicort drug for COPD and asthma

The drug is an inhalation aerosol that treats symptoms of two common pulmonary health conditions.

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