Newsletter - April 29, 2021
FDA Starts Enforcing Clinicaltrial.gov Law
Almost 14 years since the passage of the law requiring that results of clinical trials be posted within a year of trial completion, yesterday, FDA issued the first notice of non-compliance to a sponsor for violating the law, and promised stricter enforcement going forward. Ever since the creation of the clinicaltrials.gov online registry...Read More
FDA to Stem Cell Clinics: File an IND by June 1, or Close Business
For several years, stem cell clinics in the US have flourished offering treatments to patients for all kinds of ailments, despite the FDA warning that these treatments are illegal under the US regulations. That ends on 1st June 2021 when FDA will finally initiate aggressive enforcement actions against such clinics, announced FDA’s Director...Read More
FDA Starts Enforcing Clinicaltrial.gov Law
Almost 14 years since the passage of the law requiring that results of clinical trials be posted within a year of trial completion, yesterday, FDA issued the first notice of non-compliance to a sponsor for violating the law, and promised stricter enforcement going forward. Ever since the creation of the clinicaltrials.gov online registry...Read More
FDA to Stem Cell Clinics: File an IND by June 1, or Close Business
For several years, stem cell clinics in the US have flourished offering treatments to patients for all kinds of ailments, despite the FDA warning that these treatments are illegal under the US regulations. That ends on 1st June 2021 when FDA will finally initiate aggressive enforcement actions against such clinics, announced FDA’s Director...Read More
