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FDA Proposes Quality System Approach to Nonclinical Lab Studies

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Federal Register Proposed rule: FDA proposes to amend good laboratory practice for nonclinical laboratory studies regulations to r...

FDA to Revise Categories for Animal Drugs in Feed

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Federal Register Proposed rule: FDA proposes to amend the animal drug regulations by revising the definitions of the two categorie...

SRS Seeking Expanded Use for Spanner Prostatic Stent

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SRS Medical Systems gains IDE approval to enroll patients in a study to expand the indications for use for its Spanner Temporary P...

Court Backs FDA Active Moiety Interpretation

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The DC federal court says FDA acted appropriately in approving Alkermes application for Aristrada before the expiration of three-y...

FDA Orphan Status for TG Therapeutics Leukemia Therapy

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FDA grants TG Therapeutics an orphan drug designation for its next generation PI3K Delta inhibitor, TGR-1202, for treating patient...

FDA Clears Bio2 Medical Angel Catheter

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FDA clears a Bio2 Medical 510(k) for the Angel Catheter, intended for use in preventing pulmonary embolism in patients who cannot ...

FDA Revamps Minor Species Reg for Animal Drugs

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FDA announces a direct final rule intended to ensure that antimicrobial drugs used in animal feed remain available for therapeutic...

Galapagos, Gilead Launch Phase 3 Program for Arthritis Drug

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Galapagos and Gilead begin a Phase 3 clinical trial program called FINCH that will investigate the efficacy and safety of 100 mg a...

CGMP Violations in 2 Unimark Facilities

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FDA warns Unimark Remedies about CGMP violations at two active pharmaceutical ingredient manufacturing facilities in India.

FDA, Device Industry Agree to $400 Million Jump in User Fees

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FDA and the medical device industry reach an agreement in principle on the next round of user fees that will see fees skyrocket by...