The Food and Drug Administration is preparing to implement the Drug Quality and Security Act.
Medical Devices and Prescription Drug Policy
23andMe never received FDA clearance to market its DNA test kits.
Healthcare advocates are urging the White House to reject language they say would lock in high prices for biologic drugs.
Members of the House want to prevent the Centers for Medicare and Medicaid Services (CMS) from changing the rules for maintaining medical equipment that perform MRIs and other procedures.
A top Food and Drug Administration official told House lawmakers that the administration was “very concerned” about the threat of bacteria that are immune to antibiotic drugs.
The Senate voted 97-1 Tuesday to advance a drug bill aimed at creating a safer compound drug supply.
The Senate will spend part of the week debating a bill that would make it easier to trace drugs throughout the supply chain.
New draft rule would let generic drug manufacturers speed up changes to their safety labels.
The Obama administration has some reservations about legislation that would expand federal authority over pharmacies that mix drugs.
The Drug Quality and Security Act, which is likely to come up for a vote in the Senate in coming weeks, is “a step,” Food and Drug Administration (FDA) Commissioner Margaret Hamburg said on Tuesday. But it doesn’t go all the way.
“I don’t think it’s going to be as comprehensive as we initially had hoped,” she said at an event sponsored by Bloomberg Government.
The Obama administration on Thursday proposed regulations that would require drug companies to warn the government about disruptions in supply.
The Food and Drug Administration (FDA) announced it is shifting its policy on how patients can obtain certain painkillers.
Hydrocodone drugs, such as Vicodin, have long had less stringent prescribing regulations – but that could all change in early 2014, the regulator said Thursday.
For 14 years, lawmakers in the House and Senate have been urging the FDA to reclassify the drug from a Schedule III to a Schedule II drug – putting it in line with other painkillers such as morphine, fentanyl and oxycodone that require a doctor’s written prescription.