FDA Releases Final Guidance on Acne Drug Trials
Clinical trials for acne drugs should limit efficacy assessments to patients’ faces and assess results based on a drug’s effect on the number of lesions and the lesions’ severity, the…
Novartis and Par Pharmaceutical Taken to Court Over Pay-For-Delay
Novartis and Par Pharmaceutical were hit with a pay-for-delay lawsuit filed by Puerto Rican drug manufacturer Drogueria Betances alleging the two companies engaged in years of anticompetitive conduct that delayed…
FDA Pulls Plan for Risk-Based Biologics Inspections
The FDA withdrew a direct final rule to amend biologics inspection regulations and said it will rewrite it. Source: International Pharmaceutical Regulatory Monitor
FDA Issues ‘Streamlined’ Trial Guidance for Hematologic Drugs
The FDA released draft guidance on a “streamlined nonclinical program” for sponsors of nonclinical studies for development of pharmaceuticals for treatment of patients with debilitating or life-threatening hematologic disorders, saying…
EMA Issues Q&A on Health-Based Exposure Limits
The European Medicines Agency released Q&A guidance on prevention of cross-contamination and setting health-based exposure limits (HBELs) for risk identification during drug manufacturing in shared facilities. Source: International Pharmaceutical Regulatory…
FDA: Inspection Agreements With EU Done by Next Summer
The FDA is on track to complete standardized inspection agreements with every nation in the European Union next summer, one of the agency’s senior international officials said. Source: International Pharmaceutical…
Reine Lifescience Cited for Adulterated APIs
The FDA hit API manufacturer Reine Lifescience with a warning letter for significant GMP violations observed during a November inspection of its facility in Gujurat, India. Source: Drug Industry Daily
FDA Issues Draft Guidance for Antimicrobial Drugs for Cytomegalovirus
Sponsors of trials for drugs to prevent cytomegalovirus (CMV) infection in transplantation should use incidence of disease within 6 to 12 months post-transplantation as their primary endpoint, according to new…
Retailers Sue Allergan for Keeping Generic Restasis Off Market
Allergan’s contested patents for the dry-eye drug Restasis took another potential hit last week as four major retailers filed an antitrust lawsuit against the drugmaker. Source: Drug Industry Daily
FDA Warns of Lower Survival Rates for Certain Patients in Keytruda, Tecentriq Monotherapy Trials
The FDA issued an alert to clinical investigators, doctors and consumers about safety issues associated with use of Keytruda or Tecentriq as a monotherapy in oncology clinical trials. Source: Drug…
- Go to the previous page
- 1
- …
- 115
- 116
- 117
- 118
- 119
- 120
- 121
- …
- 610
- Go to the next page