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5th Annual Drug Safety Priorities Report Out

[ Price : $8.95]

CDER issues its fifth annual drug safety priorities report detailing the effort at multidisciplinary collaboration in the Center.

Priority Review Used on Migraine Drug Approval

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Federal Register notice: FDA provides notification that it approved a drug product that relied on a priority review voucher for ap...

Avid Radiopharm Alzheimers Imaging Drug Approved

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FDA approves an Avid Radiopharmaceuticals NDA for Tauvid (flortaucipir F18) for intravenous injection, the first drug for helping ...

Proprietary Names Guide for Animal Drugs

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Federal Register notice: FDA makes available a final guidance #240 entitled Proprietary Names for New Animal Drugs.

Template for Covid-19 Home Sample Kits

[ Price : $8.95]

FDA provides a voluntary EUA template for device developers to use for Covid-19 at-home sample collection kits.

FDA Orders 5 Firms to Recall Metformin

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FDA says five drug firms will need to recall their metformin drug products after sampling detected an impurity (N-Nitrosodimethyla...

Orange Book Q&A Draft Guidance

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FDA issues a draft guidance answering commonly asked questions about the drug product Orange Book.

FDA Letter on Respiration Decontaminatior

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An FDA letter reminds healthcare staff to use the correct decontamination cycle associated with certain models of Advanced Sterili...

FDA Solicits Rare Disease Trial Network Info

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FDA solicits information from a wide variety of sources on improving the design, conduct, and completion of rare disease clinical ...

CDER Naloxone Model Drug Facts Label

[ Price : $8.95]

CDER encourages industry sponsors to incorporate the Centers naloxone model drug facts label in development plans for over-the-cou...