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Breakthrough Status for Medtronic Heart Pump

[ Price : $8.95]

Medtronic gets an FDA Breakthrough Device designation for its fully implantable left ventricular assist device for patients with a...

Electronic Format for IND Safety Reports

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FDA issues a draft guidance and a final technical conformance guide on electronic submission of IND safety reports to the FDA Adve...

Drug Shortage Causes, Solutions

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An FDA-led drug shortage task force releases a report highlighting key reasons for drug shortages and potential enduring solutions...

Guide on Type V DMFs for CDER-Led Combo Products

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance for industry entitled Type V DMFs for CDER-Led Combination Products ...

Class 2 for Air-Conduction Hearing Aids

[ Price : $8.95]

Federal Register notice: FDA classifies self-fitting air-conduction hearing aids into Class 2 (special controls).

FDA Withdrawing Watson Labs Oxycodone Hydrochloride

[ Price : $8.95]

Federal Register notice: FDA proposes to withdraw approval of a Watson Laboratories ANDA for oxycodone hydrochloride and ibuprofen...

FDA Withdrawing InvaGen Trandolapril ANDA

[ Price : $8.95]

Federal Register notice: FDA proposes to withdraw approval of an InvaGen Pharmaceuticals ANDA for trandolapril tablets.

FDA Regenerative Medicine Framework is Important Step: Pew

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A Pew Charitable Trusts report praises the FDA 2017 framework on regulation of regenerative medicine as a good first step and says...

Court Rejects Innovator Liability in Generic Drug Case

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Washington Legal Foundation reports on an Idaho state court decision that rejected the legal theory that a branded drug company ca...

Continuous Pharmaceutical Manufacturing Bill In

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Reps. Pallone and Guthrie introduce bipartisan legislation to allow FDA to partner with universities as National Centers of Excell...