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HRA Pharma Files for OTC Birth Control Pill

[ Price : $8.95]

HRA Pharma files an NDA for an Rx-to-OTC switch for the companys Opill (norgestrel .075 mg), a progestin-only daily birth control ...

Former FDA Generics Official Joins Lachman Consultants

[ Price : $8.95]

After a 22-year career at FDA, CDER Office of Generic Drugs Division of Legal and Regulatory Support deputy director Martin H. Shi...

Hemophilia Group Wants REMS for 2 Investigational Gene Drugs

[ Price : $8.95]

The National Hemophilia Foundation says FDA should require a REMS for two investigational gene therapies being reviewed as hemophi...

Pharmacists Can Prescribe Paxlovid: FDA

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FDA says state-licensed pharmacists may prescribe Paxlovid but not Lagevrio.

FDA Clears VideaHealth Dental Cavity AI Algorithm

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FDA gives 510(k) clearance to a VideaHealth algorithm that can help dentists identify dental caries on patient X-rays.

Preemption in FDA Monograph OTC Cases Explained

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Two Covington & Burley attorneys review the history of court preemption decisions involving over-the-counter drug monograph produc...

FDA Self-Audit Sees Continuous Manufacturing Advantages

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CDER Office of Pharmaceutical Quality deputy director Mahesh Ramanadham outlines advantages found in an agency self-audit comparin...

FDA Withdraws Xellias Bacitracin ANDA

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Federal Register notice: FDA withdraws the approval of Xellia Pharmaceuticals ANDA for bacitracin for injection after the company ...

Comments on Medical Device VIP Program Draft Guidance

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Six stakeholders comment on an FDA draft guidance on the CDRH Voluntary Improvement Program for medical device manufacturers.

Intercept to Resubmit Obeticholic Acid NDA

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Intercept Pharmaceuticals says it will resubmit an NDA to FDA for its obeticholic acid to treat patients with liver fibrosis due t...