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Peripheral Vascular Atherectomy Device Guidance

[ Price : $8.95]

FDA issues a guidance on 510(k) submissions for peripheral vascular atherectomy devices.

2 Annual Pharmacology Reports Available

[ Price : $8.95]

The Office of Clinical Pharmacology says its annual report and the report from its Division of Applied Regulatory Science are avai...

Court Changes Drug Country of Origin Determination: Attorney

[ Price : $8.95]

Attorney Curtis Dombeck says a recent Federal Circuit Appeals Court decision has revolutionized determination of the country of or...

Info Collection on Rapid Response Surveys

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension for FDA Rapid Response Surveys.

Stop Clinical Trial Advantages in Foreign Countries: Editorial

[ Price : $8.95]

Pharmacy professor C. Michael White says FDA should eliminate advantages currently enjoyed by clinical trial sites in developing c...

Mercks Keytruda Meets Endpoint in Breast Cancer Trial

[ Price : $8.95]

Merck says that its Phase 3 KEYNOTE-355 trial investigating Keytruda (pembrolizumab), an anti-PD-1 therapy, in combination with ch...

Lupin Pithampur Inspection Has 2 Observations

[ Price : $8.95]

Equity Bulls says FDA had two observations following its inspection at the Lupin Pithampur Unit 1 facility in India.

Baxter Metabolic Monitor for Calorie Needs Cleared

[ Price : $8.95]

FDA clears a Baxter International 510(k) for the Q-NRG+, a metabolic monitoring device that uses indirect calorimetry technology t...

FTC Sues 2 Companies Over Joint Pain Products

[ Price : $8.95]

The Federal Trade Commission sues two companies to stop them from falsely claiming that their pills are scientifically proven to a...

SCA Pharmaceuticals FDA-483

[ Price : $8.95]

FDA releases the FDA-483 with two observations from an inspection at SCA Pharmaceuticals.