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Swiss-FDA Mutual Recognition Agreement

[ Price : $8.95]

FDA signs a good pharmaceutical manufacturing practice mutual recognition agreement with Switzerland and its regulatory agencies.

Implementing Cybersecurity Provision in Spending Bill

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CDRHs Suzanne Schwartz says FDA is glad it now has the legal authority to require medical device manufacturers to address cybersec...

NCVHS Should Add UDIs to Claims Forms: Article

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Researchers call on the National Committee on Vital and Health Statistics to approve a proposal to add medical device unique ident...

Biocon Complete Response Letter on Insulin Biosimilar

[ Price : $8.95]

FDA issues Biocon Biologics a complete response letter on its BLA for a biosimilar version of insulin aspart, citing additional da...

Physicians Seek Panel Review for Full Approval of Alzheimers Drug

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Physician advocacy group Doctors for America urges FDA to commit to convening an advisory committee meeting when it is time to con...

2 Olympus Endoscope Warning Letters

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FDA warns two Olympus endoscope and reprocessor manufacturing facilities about Quality System and Medical Device Reporting regulat...

PhRMA Expresses ICH Q12 Guidance Concerns

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Pharmaceutical Research and Manufacturers of America raises some issues with the International Conference on Harmonization Q12 gui...

Guide on 510(k) Submissions for Photobiomodulation Devices

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FDA posts a draft guidance entitled Photobiomodulation (PBM) Devices Premarket Notification 510(k) Submissions.

AstraZeneca Asthma Drug Approved by FDA

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FDA approves an AstraZeneca NDA for Airsupra (albuterol/budesonide) for the as-needed treatment or prevention of bronchoconstricti...

EUA Granted for Monkeypox Diagnsotic

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Federal Register notice: FDA issues an emergency use authorization for a Life Technologies in vitro diagnostic device for detectin...