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https-www-hlregulation-com-files-2019-08-us-fda-ema-offer-similar-explanations-for-adc-regulations_wrbm_large-300x225-jpg

FDA and EMA Address Quality and Manufacturing Challenges for Breakthrough Therapies Undergoing Expedited Approval

August 5, 2019

FDA introduces new standardized inspection protocols for sterile drug manufacturers to modernize and strengthen oversight

November 15, 2018

FTC takes on deceptive stem cell therapy claims for blindness cure and autism treatment

November 7, 2018
Workers inspecting packaging in pharmaceutical factory

FDA publishes internal policy on prioritizing surveillance inspections for drug manufacturing sites

September 5, 2018

FDA Shows that it Means Business in Stopping Stem Cell Clinics that Put Patients at Risk

May 11, 2018

FDA Shows that it Means Business in Stopping Stem Cell Clinics that Put Patients at Risk

May 11, 2018

FDA Shows that it Means Business in Stopping Stem Cell Clinics that Put Patients at Risk

May 11, 2018

The Crackdown Continues:  FDA Takes Action Against Company And Its Autologous Stem Cell Product, Alleging Significant Safety Concerns

January 5, 2018

FDA Issues New Guidance Documents on Regenerative Medicine but Delays Enforcement

November 17, 2017

FDA to Rely on Drug Inspections Performed by Certain European Regulatory Authorities Beginning November 1, 2017

October 31, 2017

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