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Medtronic gets an FDA Breakthrough Device designation for its fully implantable left ventricular assist device for patients with a...[ Price : $8.95]
FDA issues a draft guidance and a final technical conformance guide on electronic submission of IND safety reports to the FDA Adve...[ Price : $8.95]
An FDA-led drug shortage task force releases a report highlighting key reasons for drug shortages and potential enduring solutions...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance for industry entitled Type V DMFs for CDER-Led Combination Products ...[ Price : $8.95]
Federal Register notice: FDA classifies self-fitting air-conduction hearing aids into Class 2 (special controls).[ Price : $8.95]
Federal Register notice: FDA proposes to withdraw approval of a Watson Laboratories ANDA for oxycodone hydrochloride and ibuprofen...[ Price : $8.95]
Federal Register notice: FDA proposes to withdraw approval of an InvaGen Pharmaceuticals ANDA for trandolapril tablets.[ Price : $8.95]
A Pew Charitable Trusts report praises the FDA 2017 framework on regulation of regenerative medicine as a good first step and says...