FDA Compliance News | Quality Digest

Letitia Baldrige, Sister of Malcolm Baldrige, Dead at 86

(NIST: Gaithersburg, MD) -- Letitia Baldrige, sister of Malcolm Baldrige, died Mon., October 29, 2012, at the age of 86.

FDA Proposes Unique Device Identification System for Medical Devices

(FDA: Washington, D.C.) -- In response to requirements in legislation that passed Congress with broad bipartisan support, the U.S. Food and Drug Administration (FDA) proposed that most medical devices distributed in the United States carry a unique device identifier, or UDI.

ISPE and FDA Discussed Strengthening Safety at Joint CGMP Conference

(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE) just concluded its two-day current good manufacturing practices (CGMP) conference, which was co-sponsored by the U.S. Food and Drug Administration (FDA).

Current Good Manufacturing Practices Conference

(ISPE: Tampa, FL) -- The Food and Drug Administration (FDA) has joined with the International Society for Pharmaceutical Engineering (ISPE) to deliver an integrated learning conference focused on industry and regulatory viewpoints concerning current good manufacturing practices (CGMP).

FDA Issues Draft Guidance on Biosimilar Product Development

(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) has issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States.

FDA and Industry Reach Agreement in Principle on Medical Device User Fees

(FDA: Silver Spring, MD) -- The Food and Drug Administration (FDA) and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program.

Two Days of ISO 14971 Training

(FDAnews: Falls Church, VA) -- Is failure mode and effects analysis (FMEA) the cornerstone of your risk management program? Consider this quote from the Food and Drug Administration’s (FDA) quality systems regulation expert Kim Trautman: “Are FMEA or FMECA… good tools? Yes.