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reports (ICSR) when an event occurs in one country but is reported in another country, Sanofi says in comments to a draft guidance on the reports.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.