Weighing in on a drug preemption case that could impact the future liability of makers of biosimilars, the author of the Hatch-Waxman Amendments told the Supreme Court that the law, which opened the floodgates to generics, was intended to speed access to cheaper drugs – not to protect generic drugmakers from patient lawsuits arising from injuries caused by their drugs.
The reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA), coupled with the government's intent to purchase a large order of drugs to stockpile against the threat of a radiological/nuclear attack, should make it easier for biotechs developing medical countermeasures (MCMs) to attract investors.
The taming of the Wild West of social media has begun, with the FTC reinforcing its role as sheriff. To keep the peace and help drugmakers and other industries ride through the new digital territories unscathed, the FTC updated its 13-year-old ".com Disclosures" guidance.
Despite the continuing grip of sequestration, the FDA will breathe easier if a bipartisan Senate appropriations proposal becomes part of a hybrid spending package intended to fund the government for the remainder of fiscal 2013.
In the days before the sequester tightened Washington’s belt, the National Institutes of Health (NIH) and several other federal agencies sent up warning shots of just what was at stake. Under the automatic budget cuts intended to put the national deficit on a strict diet, the NIH expected to lose $1.6 billion from its 2013 fiscal budget. If the sequester stayed in place, NIH Director Francis Collins said the agency would give "hundreds and hundreds" fewer grants than it would have awarded otherwise, slowing down important research. Speaking at a news conference, Collins said the NIH was trying to avoid...
Beginning next week, the U.S. patent system will be in step with the rest of the world. But to keep pace, the Patent and Trademark Office (PTO) and industry will have to manage a steep learning curve as the nation switches from first-to-invent patent claims to a globally accepted first-to-file system.
Seeking to lift the veil on its approval process, the FDA released a draft five-year plan describing the steps it's taking to further develop and implement a structured benefit-risk assessment to be used in agency reviews of drugs and biologics.
Drugmakers with calcitonin salmon products under development for postmenopause osteoporosis (PMO) may have to do a lot more work to get the drugs approved following a joint FDA advisory committee meeting Tuesday.
The thin thread suspending Damocles' sword inches from federal budgets snapped Friday as Congress and the president threw up their hands on averting a sequester that will bring across-the-board cuts to most government programs, including those at the FDA and National Institutes of Health.
