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OTC Erectile Dysfunction Gel Authorized in U.S.

[ Price : $8.95]

FDA grants Futura Medical a de novo marketing authorization for over-the-counter MED3000, a topical gel formulation for treating e...

Moran Debarred for Five Years

[ Price : $8.95]

Federal Register notice: FDA issues an order to debar Luis Anarbol Moran for five years from importing any drug into the U.S.

Info Collection on Orphan Drugs

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled Orphan Drugs 21 CFR Part 316.

BIO on FDA Data, Technology Plan

[ Price : $8.95]

BIO suggests revisions to an FDA strategic plan for modernizing the agencys data and technology systems.

More Data Needed for Neffy ANDA: Viatris

[ Price : $8.95]

Viatris asks FDA to require additional PK and PD studies to support an ARS Pharmaceuticals NDA for its ARS-1 epinephrine nasal spr...

Ipsens Bylvay Gets Expanded Use

[ Price : $8.95]

FDA approves Ipsens Bylvay (odevixibat) for an expanded use treating cholestatic pruritus in patients aged 12 months and older wi...

FDA Backs New Covid Vaccine with XBB Variant

[ Price : $8.95]

FDA reviewers recommend that the Covid-19 vaccination program for the 2023-2024 season contain a monovalent vaccine comprising the...

Info Collection on MedSun Device Reporting

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension entitled Adverse Event Program for Medical Devices....

Collection on Device Premarket Notification Revised

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection revision entitled Premarket Notification of Devices.

MAPP on ANDA Facility Deficiency Reclassifiaction

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FDA posts a new CDER manual of policies and procedures (MAPP) 5021.5, Assessment of Facility-Based Deficiency Major-to-Minor Recla...