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Allecra NDA Approval for Antibiotic

[ Price : $8.95]

FDA approves an Allecra Therapeutics NDA for Exblifep (cefepime/enmetazobactam) for treating complicated urinary tract infections.

Class 1 Correction Recall on Electrodes Updated

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FDA updates a Class 1 recall (correction) of Megadyne Medical Products Mega Soft patient return electrode models to reiterate the ...

FDA Guide on Informed Consent Key Info

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FDA posts a draft guidance on Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigat...

Antibody-Drug Conjugate Pharmacology Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Clinical Pharmacology Considerations for Antibody-Drug Conj...

Device Recognized Consensus Standards Updated

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Federal Register: FDA announces a publication containing modifications the agency is making to the list of standards it recognizes...

J&J Gets Full Approval for Rybrevant

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FDA grants full approval to Johnson & Johnsons Rybrevant (amivantamab-vmjw) in combination with chemotherapy for the first-line tr...

CDRH Cautions on Breast Implant Removal

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CDRHs Binita Ashar says a recent journal article on breast implant risk provided useful information for patients and providers abo...

Antibody-Drug Conjugate Guidance

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FDA publishes a guidance to assist in the development of antibody-drug conjugates with a cytotoxic small-molecule drug or payload.

Hard for States to Meet Import Rules: Califf

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FDA commissioner Robert Califf says it is very difficult for states to meet the standards set by Congress for importing drugs from...

Electrical OR Table Problems

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FDA says it has received reports of rare adverse events involving electrical operating room tables.