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NDA for Ultragenyx Fatty Acid Oxidation Drug

[ Price : $8.95]

FDA accepts for review an Ultragenyx Pharmaceutical NDA for UX007 (triheptanoin) for treating long-chain fatty acid oxidation diso...

OssDsigns Cranial Accessories Cleared

[ Price : $8.95]

FDA clears an OssDsign 510(k) to market its Cranial PSI Accessories, which are a set of 3D-printed, patient-specific accessory dev...

FDA Misses Deadline on Blood Pressure Drugs, Group Says

[ Price : $8.95]

A public interest group says FDA has missed a self-imposed six-month deadline to assess levels of the carcinogen nitrosamine that ...

Wontech HairBoom Scalp Device Cleared

[ Price : $8.95]

FDA clears a Wontech 510(k) for its low level laser therapy hair loss treatment device, HairBoom Air.

CDRH Listing on Upcoming Guidance Documents

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Federal Register notice: FDA announces its Web site address where CDRH will post two lists of guidance documents that the Center i...

Info Collection on 510(k) 3rd-party Reviews

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Federal Register notice: FDA submits to OMB an information collection extension for 510(k) Third-Party Review Program.

Innoveix Pharma Recalls Drugs Over Sterility Concerns

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Innoveix Pharmaceuticals recalls all sterile compounded drug products due to sterility assurance concerns.

Info Collection Extension for CVM eSubmissions

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Federal Register notice: FDA sends to OMB an information collection extension for a guidance on cvms electronic submission system....

FDA Hits Cipla in India with 38-page Form-483

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FDA issues a highly redacted 38-page Form-483 following a recent inspection at drug manufacturer Cipla in Goa, India.

Lillys Reyvow Approved for Migraines

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FDA approves Eli Lillys Reyvow (lasmiditan) tablets for the acute treatment of migraine with or without aura in adults.