Clinical Trials Advisor

Sen. Kay Hagan (D-N.C.) will soon introduce legislation to expand the FDA’s use of an accelerated approval pathway that could allow sponsors to skirt some trial requirements, Biotechnology Industry Organization (BIO) officials say.

The FDA should clarify how to handle individual case safety reports (ICSR) when an event occurs in one country but is reported in another country, Sanofi says in comments to a draft guidance on the reports.

The FDA has handed Bristol-Myers Squibb (BMS) and AstraZeneca a complete response letter (CRL) for diabetes drug dapagliflozin that will probably necessitate new clinical trials, analysts say.

Access to electronic trial records systems must be limited to authorized, trained individuals who have unique passwords, an FDA official advises clinical research sites.

An updated Health Canada guidance provides advice on when to include or exclude women from drug and device trials, including women who are pregnant or breastfeeding.

Drugmakers should prepare for law enforcement agencies to expand their reach and focus more on R&D practices and trial conduct in coming years, compliance and legal experts warn.

Roche’s claims that blockbuster influenza drug Tamiflu has reduced complications and hospital stays are not supported by clinical trial data, the FDA says, as groups call for the company to release its trial findings.

Adaptive trial designs can increase a trial’s chance of success, provide quality evidence faster, shorten investigational timelines by combining trial phases and reduce the overall sample size required, Olga Marchenko, vice president at Quintiles, a leading CRO, said during a recent FDAnews webinar.

Tanzania’s Food and Drugs Authority (TFDA) has issued draft guidelines for sponsors, investigators and CROs on reporting safety data and on compensation in clinical trials.

Sandoz is looking to continue its global lead in biosimilars by launching two new Phase III trials on separate Amgen products.

An FDA advisory committee voted 13–4 against recommending approval for Columbia Laboratories’ Prochieve progesterone gel, citing efficacy concerns and a lack of confidence in the company’s sole late-stage trial.