FDA Related News

Federal Register

Fee for Tropical Disease Priority Review Voucher

Federal Register notice: FDA announces the fee rate of $2,167,116 for using a tropical disease priority review voucher for fiscal year 2020.

Federal Register

Guide on Animal Drug Expanded Conditional Approval

Federal Register notice: FDA makes available a draft guidance for industry #261 entitled Eligibility Criteria for Expanded Conditional Approval of New...

Human Drugs

FDA/DEA Warn Online Opioid Marketers

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

Medical Devices

FDA Clears CivaTech Skin Cancer Patch

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

Human Drugs

U.S. Specialty Formulations Cited on Inspection

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

Human Drugs

Fee for Pediatric Priority Review Voucher

Federal Register notice: FDA announces the fee rate of $2,167,116 for using a pediatric disease priority review voucher for fiscal year 2020.

Federal Register

Medical Countermeasure Priority Review Voucher

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

Avanir Pharma Charged in Marketing Scheme

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

Human Drugs

Guide on Patient-Focused Drug Development

FDA posts a draft guidance on Patient-Focused Drug Development: Methods to Identify What Is Important to Patients.

Medical Devices

FDA Review on Amalgam Finds No Direct Safety Concern

A new FDA literature review on dental amalgam safety finds no sufficient evidence of a relationship between clinically detectable adverse health outco...