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Cook Medical Class 1 Recall of 2 Flexor Catheters

[ Price : $8.95]

FDA says the Cook Medical recall of two Flexor introducers is Class 1.

FDA Approves Ridgeback Ebanga Ebolavirus Treatment

[ Price : $8.95]

FDA approves Ridgebacks Ebanga human monoclonal antibody for treating Zaire ebolavirus.

FDA Strengthens TIRF Opioid Product REMS

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FDA strengthens the REMS for transmucosal immediate-release fentanyl products to help ensure proper prescribing to opioid-tolerant...

REMS Electronic Format Guidance

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FDA issues a final guidance on the content of REMS documents submitted electronically in structured product labeling.

Pandemic CRL Response Timelines

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FDA issues a guidance on review times for certain complete response letters during the pandemic.

Consumer Antiseptic Rub Final Rule Q&A

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FDA publishes a question-and-answer guidance on the consumer antiseptic rub final rule.

WLF Urges 7th Circuit to Uphold Innovation Decision

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Washington Legal Foundation asks an appeals court to uphold a lower court decision that a Humira patent settlement between AbbVie ...

Withdraw Insulin Reimportation Proposal Request: PhRMA

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PhRMA asks FDA to withdraw its request for proposals for reimportation of insulin.

Individualized Antisense Oligonucleotide IND Guidance

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FDA issues a draft guidance to help sponsors develop individualized antisense oligonucleotide drug products.

Federal Register Notices: Week Ending 1/1/2021

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Federal Register notices published the week ending 1/01/2021 while we were on our annual holiday break.