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FDA Clears Child Face Mask

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FDA clears a Kimberly-Clark child face mask to help reduce spread of airborne pathogens.

Chelsea Therapeutics Submits NDA for Northera

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Chelsea Therapeutics submits an NDA to FDA for Northera for treating neurogenic orthostatic hypotension.

FDA, Hill Under Consent Decree

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FDA says it has entered into a consent decree with Hill Dermaceuticals, Hill Labs, and two individuals over CGMP and other problem...

Horizon Submits Lodotra NDA

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Horizon submits an NDA to FDA for Lodotra to treat active rheumatoid arthritis.

Paragraph 4 Needed for 30-month Stay: Court

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A North Carolina federal judge vacates a 30-month patent litigation stay after the ANDA applicant changes from a Paragraph 4 certi...

Onyx Pharma Completes NDA for Multiple Myleoma Treatment

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Onyx Pharmaceuticals completes an NDA filing with FDA for carfilzomib for treating patients with relapsed and refractory multiple ...

Info on CGMPs for Finished Pharmaceuticals Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on current good manufacturing practice regulations for fin...

Guidance on New Tobacco Product Applications

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Federal Register Notice: FDA releases a draft guidance on applications for premarket review of new tobacco products.

HHS Rebuts Commentary on New Media Rules

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HHS rebuts some statements made in a commentary by FDA Webview editor Jim Dickinson.

Drug Companies Must Release All Trial Results

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Researchers say that drug companies have an ethical duty to publish clinical trial results even if they dont continue to develop a...