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While the main thrust of the European Union's Clinical Trial Directive is to better protect study participants, it is also intended to make the EU more attractive for clinical research by shortening the approval process for trials and streamlining bureaucracy.
The FDA has extended the review period for Somerset Pharmaceuticals’ Emsam, an investigational transdermal patch for the acute and maintenance treatment of major depressive disorder.
The HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP) lauded a recent draft guidance on adverse event reporting at its recent meeting in Washington, D.C. SACHRP also grilled the FDA about when it could expect similar guidance from the agency.
Mixed results from two Phase II clinical trials could delay Pfizer’s launch of its next-generation Lipitor product by as long as two years, according to a Wall Street analyst.
Mixed results from two Phase II clinical trials could delay Pfizer’s launch of its next-generation Lipitor product by as long as two years, according to a Wall Street analyst.
Sponsors should conduct pediatric clinical trials as a means to both advance medical knowledge and avoid having products designated as misbranded, according to an industry expert.
The Center for Drug Evaluation and Research (CDER) plans to start conducting linked inspections of institutional review boards (IRBs) and clinical investigators (CIs) to gain a more comprehensive picture of what goes on between the two entities, an FDA official said.
If approved by the FDA, Merck and Bristol-Myers Squibb’s (BMS) highly anticipated diabetes treatment Pargluva would “constitute an unacceptable patient hazard,” according to an independent clinical analysis that shows the drug poses significant safety risks.
The Office of Human Research Protections (OHRP) has issued guidance to institutional review boards (IRBs) for reviewing information provided on clinical trial websites.
The Center for Drug Evaluation and Research (CDER) will start conducting linked inspections of institutional review boards (IRBs) and clinical investigators (CIs) to gain a more comprehensive picture of what goes on between the two entities, an FDA official said.