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OPDP Core Launch Review Process Updated

[ Price : $8.95]

An 11/20 CDER Webinar will explain changes to the Office of Prescription Drug Promotion core launch review process.

Vaccine Electronic Safety Report Info

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FDA posts online information for vaccine manufacturers to submit safety reports electronically to CBER.

Armis Biopharmas Toe Implant Approved

[ Price : $8.95]

FDA approves Armis Biopharmas VeriFixx Small Bone Implant for the fixation of osteotomies and reconstruction of the lesser toes fo...

Regenerative Cell Institute Illegally Marketing Cellular Products: FDA

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FDA says Regenerative Cell Institute in Las Vegas is illegally providing cellular products to treat many diseases and conditions.

FDA Clears EOGas 4 Ethylene Oxide Gas Sterilizer

[ Price : $8.95]

FDA clears an Andersen Sterilizer 510(k) for its EOGas 4 Ethylene Oxide Gas Sterilizer and associated accessories for sterilizing ...

FDA Approves Modified Definity for Echocardiograms

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FDA approves a Lantheus Holdings/Progenics Pharmaceuticals supplemental NDA for Definity Room Temperature (perflutren lipid micros...

Oncology Drug Cross Labeling Guidance

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FDA issues a draft guidance with recommendations on cross labeling oncology drugs used in combination regimens.

Drug Recalls Up, Device Recalls Down: Report

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The Stericycle recall index for the third quarter of 2020 finds that drug recalls nearly doubled, while medical device recalls fel...

BPCIA and Biosimilar Development Q&A

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FDA issues a draft guidance with additional questions and answers on biosimilar development and the Biologics Price Competition an...

FDA Will Review Alvotech BLA for Humira Biosimilar

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FDA has accepted for review an Alvotech USA BLA for a Humira biosimilar.