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FDA issues a guidance on 510(k) submissions for peripheral vascular atherectomy devices.[ Price : $8.95]
The Office of Clinical Pharmacology says its annual report and the report from its Division of Applied Regulatory Science are avai...[ Price : $8.95]
Attorney Curtis Dombeck says a recent Federal Circuit Appeals Court decision has revolutionized determination of the country of or...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension for FDA Rapid Response Surveys.[ Price : $8.95]
Pharmacy professor C. Michael White says FDA should eliminate advantages currently enjoyed by clinical trial sites in developing c...[ Price : $8.95]
Merck says that its Phase 3 KEYNOTE-355 trial investigating Keytruda (pembrolizumab), an anti-PD-1 therapy, in combination with ch...[ Price : $8.95]
Equity Bulls says FDA had two observations following its inspection at the Lupin Pithampur Unit 1 facility in India.[ Price : $8.95]
FDA clears a Baxter International 510(k) for the Q-NRG+, a metabolic monitoring device that uses indirect calorimetry technology t...