Sponsors of biosimilars must demonstrate similarity, not safety and efficacy, FDA officials reiterated as they discussed ways to do that at an advisory committee meeting Wednesday.
In passing PDUFA V, Congress piled on the homework for the FDA, and much of it has nothing to do with user fees. Some of the assignments, for instance, deal with implementing incentives for new antibiotics.
Hoping to make shortages of critical drugs more the exception than the rule, the generic drug industry is diving into an initiative to give the FDA access to timely manufacturing data.
In an agency first, the FDA is rescinding an orphan drug exclusivity, saying it made a mistake two years ago in determining that Octapharma USA Inc.'s Wilate was superior to CSL Behring LLC's previously approved Humate-P.
What’s the difference between Congress and a Rube Goldberg contraption? They both use convoluted processes to accomplish a simple task, but the Goldberg invention still manages to keep the end result pretty simple. And while there may be some unintended consequences with both, they’re not unexpected with the absurd processes of a Goldberg machine. One look shows you what kind of mess you’re going to have if the cracker misses its mark, the parrot misses its perch, the seeds miss the bucket, the cigar lighter misses the fuse . . . Not so with Congress. By the time all 435...
WASHINGTON – In vacating a preliminary injunction that protected Momenta Pharmaceuticals Inc.'s $1 billion a year monopoly on generic Lovenox, the Federal Circuit gave the makers of generic drugs a much wider safe harbor under Hatch-Waxman.
WASHINGTON – Optimer Pharmaceuticals Inc.'s Dificid hit the market a few years too soon to take advantage of the exclusivity offered for new antibiotics under the FDA Safety and Innovation Act (FDASIA), but the Clostridium difficile-fighting drug is getting a regulatory hand up from another agency.
In the heat of the race for an interferon-free treatment for hepatitis C virus (HCV), Bristol-Myers Squibb Co. (BMS) stumbled over a serious safety issue in a Phase IIb trial of BMS-986094.
WASHINGTON – Hoping it will merely be an exercise in emergency planning, the FDA, National Institutes of Health (NIH) and other federal agencies are being told to begin preparing for sequestration – the across-the-board budget cuts in discretionary spending that will be triggered in January if Congress fails to trim $1.2 trillion from the national deficit.
If the FDA follows through on an advisory committee's recommendations, patients may finally have drug options to fight two conditions that can lead to permanent loss of vision.
