New Guidances Released by FDA in August 2012

It’s been a slow summer at FDA, with only four new guidances issued in the month of August 2012:

• Draft Guidance for Industry: Self-Identification of Generic Drug Facilities, Sites, and Organizations
• Draft Guidance for Industry: Self-Identification of Generic Drug Facilities, Sites, and Organizations
• Draft Guidance for Industry and Food and Drug Administration Staff – Refuse to Accept Policy for 510(k)s
• Guidance for Industry and Food and Drug Administration Staff and Foreign Governments – FY 2013 Medical Device User Fee Small Business Qualification and Certification

Related articles:

• FDASIA, Part 1: The “UFAs”
• FDASIA, Part 2: Pediatric Drugs and Devices and Medical Device Regulatory Improvements
• FDASIA, Part 3: Generating Antibiotic Incentives Now (GAIN) and Drug Approval and Patient Access Changes
• FDASIA, Part 4: Drug Supply Chain, Drug Shortages, and Other Provisions
• Biomarkers: Where are We Today?