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FDA Report on Generic Drug Approval Cost Savings

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An FDA report says generic drug approvals in 2018-2020 led to billions of dollars in savings.

FDA in Pistoia Alliance Working Group

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CDER representatives will participate in an In Vitro Pharmacology working group being assembled by Pistoia Alliance.

User Fee Reauthorization Talks Continue

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Congressional negotiations on FDA user fee reauthorization are continuing, with some major changes in play, according to Politico....

Medtronic Recalls Electromyogram Endotracheal Tubes

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Medtronic recalls its Xomed NIM Contact Reinforced Electromyogram (EMG) Endotracheal Tube and the NIM Standard Reinforced EMG Endo...

Inspection Form 483 for Alvotech Released by FDA

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FDA releases the FDA-483 citing 13 observations that were at the center of an Alvotech-received complete response letter on its bi...

FDA Denies Petition on Colonoscopy Preparation

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FDA denies a Braintree citizen petition that asked it not to approve a tablet-based or tablet-containing colonoscopy preparation u...

Guide on Monkeypox Diagnostic Tests

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Federal Register notice: FDA makes available a final guidance entitled Policy for Monkeypox Tests To Address the Public Health Eme...

Proposed OTC Contraceptive Heads to Panel

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Federal Register notice: FDA announces an 11/18 joint advisory committee meeting to discuss a Laboratoire HRA Pharma supplemental ...

Streamlined GMP Requirements for Combo Products

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Federal Register notice: FDA finalizes a list of alternative or streamlined mechanisms for complying with GMP requirements for com...

Guidance for Computer Software Assurance for Devices

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FDA publishes a draft guidance entitled Computer Software Assurance for Production and Quality System Software that the agency say...