The FDA has issued guidance outlining recommendations for studying the safety of drugs and biologics used during pregnancy after products receive approval.
The guidance describes several methodologies drugmakers can use in postapproval settings to collect pregnancy safety data, including pregnancy registries, real-world data studies and descriptive studies based on individual case reports, according to a May 8 FDA news release.
The agency said many medications are prescribed during pregnancy despite limited human safety data available at the time of approval. The guidance recommends sponsors use established scientific standards for observational research alongside existing FDA guidelines on study design, pharmacovigilance, real-world data and postmarket requirements.
“Pregnant women and their healthcare providers need clear, reliable information to make informed treatment decisions,” FDA Commissioner Marty Makary, MD, said in the release. “This guidance supports better ways to collect safety data, so clinicians have more useful information when counseling patients during pregnancy.”
The guidance comes days after the Supreme Court temporarily stayed a lower court ruling that would have blocked mail-order distribution of mifepristone, an FDA-approved abortion drug. The stay paused a May 1 appeals court decision that found the FDA’s approval of mail-order dispensing was “likely unlawful.”
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