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Fee for Pediatric Priority Review Voucher

[ Price : $8.95]

Federal Register notice: FDA announces the fee rate of $2,167,116 for using a pediatric disease priority review voucher for fiscal...

Medical Countermeasure Priority Review Voucher

[ Price : $8.95]

Federal Register notice: FDA announces the fee rate of $2,167,116 for using a material threat medical countermeasure priority revi...

Avanir Pharma Charged in Marketing Scheme

[ Price : $8.95]

The government charges Avanir Pharmaceuticals and four individuals for paying kickbacks to a physician to induce prescribing of it...

Guide on Patient-Focused Drug Development

[ Price : $8.95]

FDA posts a draft guidance on Patient-Focused Drug Development: Methods to Identify What Is Important to Patients.

Fee for Tropical Disease Priority Review Voucher

[ Price : $8.95]

Federal Register notice: FDA announces the fee rate of $2,167,116 for using a tropical disease priority review voucher for fiscal ...

Guide on Animal Drug Expanded Conditional Approval

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance for industry #261 entitled Eligibility Criteria for Expanded Conditi...

FDA/DEA Warn Online Opioid Marketers

[ Price : $8.95]

FDA and the U.S. Drug Enforcement Administration issue joint Warning Letters to four online networks that were illegally marketing...

FDA Clears CivaTech Skin Cancer Patch

[ Price : $8.95]

FDA clears a CivaTech Oncology 510(k) for its CivaDerm, a radiation therapy bandage designed for intraoperative or surface radiati...

U.S. Specialty Formulations Cited on Inspection

[ Price : $8.95]

FDA posts an 11-item Form FDA-483 to U.S. Specialty Formulations after concluding an inspection of its Bethlehem, PA manufacturing...

Guide on Type A Medicated Articles

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guide on demonstrating bioequivalence for soluble powder oral dosage form pro...