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Home » Topics » Drugs » GMPs

GMPs
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Warning Letter Roundup: FDA Flags Labeling, Sterility, Other Violations

December 11, 2017
The FDA warned four companies for illegally branding cannabidiol products as treatments for cancer and Alzheimer’s disease. Read More

European Commission Issues New GMP Guidelines for Advanced Therapies

December 11, 2017
The European Commission released new GMP guidelines for manufacturers of advanced therapy medicinal products that adapts existing European Union GMP guidelines to the specific characteristics of ATMPs and calls for a risk-based approach. Read More

FDA to Recognize GMP Inspections From Eight EU Countries

December 11, 2017
The FDA will begin to recognize manufacturing facility inspections conducted by drug regulatory authorities in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the U.K as capable of meeting the agency’s requirements, as part of 1998 agreement between the U.S. and the European Union renegotiated earlier this year. Read More

European Commission Issues New GMP Guidelines for Advanced Therapies

December 10, 2017
The European Commission released new GMP guidelines for manufacturers of advanced therapy medicinal products that adapts existing European Union GMP guidelines to the specific characteristics of ATMPs and calls for a risk-based approach. Read More

European Commission Issues New GMP Guidelines for Advanced Therapies

November 29, 2017
The new guidelines are effective May 22, 2018. Read More

European Commission Issues New GMP Guidelines for Advanced Therapies

November 27, 2017
The European Commission released new GMP guidelines for manufacturers of advanced therapy medicinal products that adapts existing European Union GMP guidelines to the specific characteristics of ATMPs and calls for a risk-based approach. Read More

FDA Shoots Down Imports From South Korean Drugmaker

September 22, 2017
The FDA blocked imports from a South Korean manufacturer of over-the-counter medical products after agency inspectors reported violations of current good management practices. Read More

FDA Shoots Down Imports From South Korean Drugmaker

September 21, 2017
Firson’s products include burn ointments, nasal sprays, hand sanitizers, enemas and treatments for excessive sweating. Read More

German Inspectors Fault Dr. Reddy’s Facility in India, Call for EU Import Ban

September 19, 2017
German health officials called for a ban on imports to the European Union from a plant operated by Dr. Reddy’s Laboratories in India, following inspections finding poor quality controls, dirty equipment, and other shortcomings. Read More

FDA Shoots Down Imports From South Korean Drugmaker

September 19, 2017
The FDA blocked imports from a South Korean manufacturer of over-the-counter medical products after agency inspectors reported violations of current good management practices. Read More

German Inspectors Fault Dr. Reddy’s Facility in India, Call for EU Import Ban

September 7, 2017
German health officials called for a ban on imports to the European Union from a plant operated by Dr. Reddy’s Laboratories in India, following inspections finding poor quality controls, dirty equipment, and other shortcomings. Read More

German Inspectors Fault Dr. Reddy’s Facility in India, Call for EU Import Ban

August 19, 2017
German health officials called for a ban on imports to the European Union from a plant operated by Dr. Reddy’s Laboratories in India, following inspections finding poor quality controls, dirty equipment, and other shortcomings. Read More
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