Drugmakers have 13 months to revamp how they track drugs after the Senate voted Nov. 18 to send to President Barack Obama’s desk a measure that would establish a nationwide track-and-trace requirement for prescription drugs. Read More

The FDA is proposing to give generic drugmakers the power to revise product labeling in response to safety issues prior to agency approval — a power that brand drugmakers already have. Read More

Just months after Sanofi began preparing regulatory filings for its blood cancer drug candidate fedratinib, the company said Monday newly raised safety concerns have forced it to scrap its plans. Read More

A drug’s active ingredient name does not need to appear every time its brand name is repeated in an advertisement, the FDA says, clarifying the most common advertising issue that drugmakers question the agency about. Read More

Congress rejected the FDA’s call for mandatory oversight of compounding pharmacies, passing legislation Monday that instead allows compounders to volunteer for agency oversight. Read More

Drugmakers have 13 months to revamp how they track drugs after the Senate voted Monday to send to President Barack Obama’s desk a measure that would establish a nationwide track-and-trace requirement for prescription drugs. Read More

The FDA has handed Daiichi Sankyo an untitled letter for making claims in a brochure that two of its hypertension treatments helped lower blood pressure in patients with severe hypertension, despite a lack of substantial supportive evidence. Read More

A panel of FDA advisors Nov. 14 overwhelmingly voted against approval of Sanofi’s Lemtrada for an expanded indication to treat relapsing multiple sclerosis (MS). Read More