Including the patient voice in the drug approval process could produce a fundamental shift in the risk-benefit equation of a new drug. But first, the FDA has to figure out how to do it, and that may take a broader societal discussion, FDA Commissioner Margaret Hamburg said. Speaking at the annual meeting of the Pharmaceutical Research and Manufacturers of America, Hamburg ticked off a few issues that we as a society must address. For instance, in the absence of a cure, patients with chronic or terminal diseases want a better quality of the life they have left. But the FDA...

Lengthening delays in the Drug Enforcement Administration's (DEA) scheduling of new prescription drugs as controlled substances are impeding patient access to much-needed therapies and could be costing lives, a House subcommittee was told during a hearing on legislation intended to improve transparency and predictability at both the DEA and FDA.

In the midst of escalating criticism about its approval of Zohydro ER (hydrocodone), the FDA approved Kaleo Inc.’s Evzio (naloxone autoinjector) to rapidly reverse an opioid overdose.

Anticipating FDA approval early next year of its infliximab biosimilar, Celltrion Inc. is trying to clear the patent path so it can launch Remsima in the U.S. as soon as the approval comes down.

If the FDA approved drugs and devices based on the populations adequately tested in clinical trials, most medical products would be indicated only for white men younger than 65.

Citing the need for a bigger arsenal in the war against infectious diseases, the FDA’s Anti-infective Drugs Advisory Committee (AIDAC) unanimously supported approval Monday of two new weapons to treat acute bacterial skin and skin structure infections caused by certain gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).

The FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) unanimously voted against recommending approval for Novartis AG’s serelaxin based on the strength of a single pivotal trial in acute heart failure (AHF).

Balancing the realities of budget constraints with the tantalizing promise of biomedical research, a House appropriations subcommittee Wednesday looked for ways to deliver on the promise at the National Institutes of Health (NIH) while living within the means of fiscal 2015 spending caps.

If the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) follows the lead of FDA reviewers Thursday, it will send Novartis AG’s serelaxin back for more testing.

Caught in the crossfire of an innovator drug company and the sponsor of a 505(b)(2) drug, the FDA is now facing a lawsuit for not assigning a therapeutic equivalence (TE) rating to Perrigo Israel Pharmaceuticals Ltd.’s testosterone gel 1 percent, which was approved more than a year ago based on its bioequivalence to Abbvie Inc.’s Androgel.