Clinical Trials Advisor

Sponsors of replacement heart valves finally have the FDA’s thinking on preclinical and clinical studies to support investigational device exemptions and premarket approval applications for their products.

If research institutions do not voluntarily strengthen their conflict-of-interest policies and procedures, pressure for external regulations is likely to increase, HHS Inspector General Daniel Levinson said as he called on the FDA and NIH to step up their oversight.

Bracco Diagnostics made false and unsubstantiated claims about its diagnostic agent Isovue and omitted or minimized risks on a website that based the claims on a clinical study, an FDA untitled letter says.

The FDA has adopted the final version of an International Conference on Harmonisation (ICH) guidance on harmonizing standards for nonclinical safety studies that support clinical trials and marketing authorizations.

The FDA has entered an agreement with the nonprofit PATH that could lead to several clinical trials of pneumococcal vaccines for children in developing countries.

For the first time in more than eight years, the FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) has sent an untitled letter to an individual investigator rather than a product’s sponsor for improper promotion.

Sites can identify unanticipated adverse events earlier by monitoring certain patient signals and using the correct tests, an expert says.

Cephalon is disclosing payments to physicians and related entities as required by a corporate integrity agreement (CIA) it entered with the HHS Office of Inspector General (OIG).

Sen. Chuck Grassley (R-Iowa) is asking the director of the National Institute of Mental Health (NIMH) to hand over communication received by his office, as part of an investigation into researchers’ financial ties with drugmakers.

Sponsors conducting bioequivalence studies for drugs with immediate release dosage forms and systemic action should design the studies so formulation effects can be distinguished from other effects.

The European Medicines Agency (EMEA) advises sponsors of epileptic disorder treatments in Phase III trials to use certain primary endpoints and include an adequate number of geriatric patients.

A complete response letter to SkyePharma may require the company to conduct more trials on its asthma drug Flutiform and possibly delay approval.

Keryx’s potential first-in-class treatment for advanced metastatic colon cancer improved overall survival in one of many Phase II trials for several types of tumors, and the company hopes to finalize a Phase III trial design in the next three months.

Pervasis Therapeutics is starting a Phase III study of its hemodialysis access graft failure treatment Vascugel now that the FDA has agreed to permit a special protocol assessment for it.