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Mycobacterial Pulmonary Disease Draft Guide

[ Price : $8.95]

Federal Register notice: FDA publishes a draft guidance entitled Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobact...

Generic Drug Warning Letter Meetings Guide

[ Price : $8.95]

Federal Register notice: FDA posts a draft guidance entitled Post-Warning Letter Meetings Under GDUFA.

35 No-Longer-Marketed NDAs Withdrawn

[ Price : $8.95]

Federal Register notice: FDA withdraws 35 no-longer-marketed NDAs from multiple applicants.

Meeting on Reauthorizing OTC Drug User Fees

[ Price : $8.95]

Federal Register notice: FDA announces a public meeting to discuss proposed recommendations for the reauthorization of the Over-th...

Green Pharma Warned Over CGMP Issues

[ Price : $8.95]

FDA warns South Koreas Green Pharmaceutical Co. in Jincheon about CGMP violations in its manufacturing of over-the-counter drugs.

Interoperable Info Exchange Guidance

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FDA publishes an updated guidance on standards for the interoperable exchange of information for tracing certain drugs under the D...

Emergency Preparedness Supply Chain

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FDA posts recommendations for healthcare providers, medical device manufacturers, and distributors on best practices in preparing ...

Robot Authorized to Disinfect Medical Surfaces

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FDA grants Xenex Disinfection Services a de novo marketing authorization for the companys LightStrike+ device, a broad-spectrum ul...

Urgent Action on Puberty Blockers Sought

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Individuals and organizations opposed to using puberty blockers in gender identity treatment for minors ask FDA to take several st...

FDA Informed Consent Final Guidance

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Six Epstein Becker Green attorneys analyze an FDA final guidance on informed consent that leaves the door open to future changes a...