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Likely FDA Impact of the Government Shutdown: Regulatory Submission Reviews, Inspections, and Research Projects

USA - December 27 2018 The U.S. government shutdown that began December 22, 2018 affected only about a quarter of federal agencies, because most had already been funded for...

Jonathan S. Kahan, Janice M. Hogan, Philip Katz, Randy Prebula.

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

USA - November 15 2018 On November 9, FDA Commissioner Scott Gottlieb, M.D., announced that the agency launched new inspection protocols for aseptic processing of sterile...

Lowell Zeta, James R. Johnson.

FDA and DoD strengthen collaboration for medical products with military applications that could also be expanded to the general population

USA - November 8 2018 On November 2, FDA and the Department of Defense’s (DoD) Office of Health Affairs signed a Memorandum of Understanding (MoU) that formally establishes...

Mike Druckman.

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

USA - November 7 2018 On October 18, the Federal Trade Commission (FTC) announced it settled charges against California-based Regenerative Medical Group, Telehealth Medical...

Lowell Zeta, Susan S. Lee.

12 Years Later: Court Prohibits Marketing of Prescription Versions of OTC Drug

USA - November 5 2018 In a big win for the Food and Drug Administration (FDA), the D.C. Circuit of the United States Court of Appeals reinforced FDA’s position on what...

Bert Lao, Heidi Gertner.