French health authorities have shut down a rogue and what they describe as an “in the wild” clinical trial involving 350 participants, conducted in a western French abbey. While running this illicit test of hormone-steeped skin patches on hundreds of Parkinson’s and...
Inspection
Category
FDA Issues Warning Letter to Principal Investigator: The Excuse Pushed us to Report on the Incident
Earlier this year, the Food and Drug Administration’s (FDA) Bioresearch Monitoring Program summarized an inspection of principal investigator (PI) Susan P. King-Harris, D.P.M., who was conducting a sponsor-initiated clinical trial involving bunion surgery. Led by the...
Has the FDA Enforcement Apparatus Gone on Hiatus Under Trump?
By several measures, Food and Drug Administration (FDA) enforcement activities have plummeted since President Trump took office. From monitoring clinical trials and approving medicines and vaccines to ensuring the safety of blood transfusions, medical devices,...
Delhi Government to Inspect 35 State Run Hospitals Due to Dilapidated Health System in Public Hospitals
The high court of India will order the inspection by an expert committee of at least 35 state-run hospitals including GB Pant, Lok Nayak, Jai Prakash, Tegh Bahadur, and Deen Dayal Upadhyay hospitals. The 8 member expert committee will be led by DS Negri, principal...
Expansive FDA Inspection Powers Reaffirmed with Limits
Bill Donovan recently wrote the Food and Drug Administration’s (FDA) vast and extensive inspection powers were reaffirmed by a Pennsylvania court. Ruling on the “inspection warrant” the court ruled that the FDA maintains the authority to secure court ordered warrant...
Veeda Clinical Achieves Successful Malaysian Agency Inspection
Veeda Clinical, an Asian mid-market CRO, reports it has successfully cleared 60 regulatory audits in the last 14 months, including 19 USFDA inspections of its facilities and clinical trial sites in last 24 months. Its clinical facility is in Shivalik, Ahmedabad and...
Pakistani Drug Regulatory Authorities Intensify GcP Lab and Clinical Site Inspections
Pakistan Observer reported the officials of the health department have started regular inspections of private laboratories and clinical centers to improve quality of health and sealed several medical stores in district Buner. These inspections started on directives of...
Clinical Supply Chain Vendor Almac Passes Singapore HAS Inspections
Murielle Gonzalez of Clean Room Technology reports Almac Group has announced that its facility in Singapore received a renewal of its GMP/GDP certification following the successful regulatory inspection by the Health Sciences Authority (HSA). This accreditation was...