GMPs

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April 17, 2020
FDA Eases Requirements for Some Compounded COVID-19 Drugs
The FDA is temporarily easing its requirements for more than a dozen compounded drugs needed for hospitalized COVID-19 patients.
September 26, 2018
FDA Warns Indian OTC Facility for Quality Violations
The facility lacked proper validation and verification studies.
September 25, 2018
FDA Warns Indian OTC Facility for Quality Violations
The FDA issued a warning letter to Wilson Medicine Company citing serious quality problems found during a Feb. 26-March 1 inspection of its OTC manufacturing facility in Nandore, India.

February 15, 2018
FDA to Define GMPs for Outsourcing Facilities
December 19, 2017
European Commission Issues New GMP Guidelines for Advanced Therapies
December 11, 2017
Morrison Says ORA Reorganization Will Mean More Foreign Inspections
December 11, 2017
Warning Letter Roundup: FDA Flags Labeling, Sterility, Other Violations
December 11, 2017
European Commission Issues New GMP Guidelines for Advanced Therapies

December 11, 2017
FDA to Recognize GMP Inspections From Eight EU Countries
December 10, 2017
European Commission Issues New GMP Guidelines for Advanced Therapies
November 29, 2017
European Commission Issues New GMP Guidelines for Advanced Therapies
November 27, 2017
European Commission Issues New GMP Guidelines for Advanced Therapies
September 22, 2017
FDA Shoots Down Imports From South Korean Drugmaker