The White House played political hardball with drug industry honchos to get a 2009 deal that...
Lawmakers are finalizing legislation to reauthorize the Prescription Drug User Fee Act , the...
The U.S. Food and Drug Administration cannot determine whether its four-year-old Risk Evaluation and Mitigation Strategies program is working because drug companies have not provided key information when requested and the agency has not taken enforcement action against them.
The neverending din of partisan squabbling coming out of Washington can be deafening at times. Luckily for everyone, legislation like The Food and Drug Administration Safety and Innovation Act of 2012 seemed more or less immune to this cacophony, passing the Senate with 92 yay votes.
It has been a long and winding road for gene therapy, but on July 20, the European Medicines Agency recommended the approval of Glybera, a gene therapy for the treatment of lipoprotein lipase deficiency, a rare hereditary disorder, developed by uniQure.
The U.S. Food and Drug Administration published draft guidance entitled Drug Interaction Studies - Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations.
Who, how, when, or even if. These are questions at the heart of the international debate over the genetic manipulation of the deadly H5N1 strain of bird flu to make it more transmissible.
GMPs and other guidelines can help suppliers and pharmaceutical manufactures improve product quality, with greater efficiency and reliability.
The Congressional Budget Office has analyzed a much-anticipated bill that bans pay-to-delay out-of-court settlements between pharmaceutical companies and generic drug makers. They estimated that the bill would result in savings of up to $5.2 billion for the government over the next 10 years.
The Food and Drug Administration said it is making labeling changes to statins like Pfizer's Lipitor, AstraZeneca's Crestor and Merck & Co. Inc.'s Zocor.
This webinar discusses the methodologies used to characterize sub-visible particulates in parenterals, Dynamic Image Analysis for particulate characterization and orthogonal instrument methodologies.
Pharmaceutical companies that provide products covered by Medicare, Medicaid, or CHIP will be required to disclose to the federal government the name of any physician and researcher to whom a monetary payment "or other transfers of value" had been made.
As lawmakers continue to grapple with the nation’s burgeoning federal budget deficit, healthcare spending has moved into the cross-hairs of fiscal and legislative debate.
The U.S. Food and Drug Administration will soon send Congress its recommendations for reauthorizing the Prescription Drug User Fee Act. The law allows the agency to hire additional staff to speed the review of applications for new drugs and biological products.
Sometimes, life can use a little excitement. Here in Northern New Jersey, we’ve had enough in the past week to last for a long time.
The absence of an abbreviated U.S. Food and Drug Administration approval pathway for biologics was addressed in March 2010 when Congress passed the Biologics Price Competition and Innovation Act.
Draft guidance released by the FDA is intended to provide stakeholders in the nanotechnology field with a framework with which they, and the agency, will construct a greater regulatory understanding. What are the potentials and pitfalls of this emerging technology?
As we prepare for increased use of comparative effectiveness research, a new study finds that only about half of the new drugs approved by the U.S. Food and Drug Administration during the past decade had CER data available from the manufacturer.
Often heard advice for the entrepreneurial set is: “Be a credible threat.” That of course is a tall order. The odds and costs are stark. Historically, only 1 in 10 lead candidates make it through to approval, and this number is likely to be lower in 2010. If this weren’t daunting enough, the failure-inclusive cost of developing that one drug is thought to be a billion dollars.
Strategic plans are a lot like New Year’s resolutions. The creators have the best intentions, but implementing the plan may be another story.
Nature is winning the microbial battle against current antibiotics. Legislative and regulatory incentives may be needed to entice developers back into the fight.
After more than half a dozen years of wrangling, Congress is moving closer to approving the first major update to the U.S. patent system in nearly six decades.
Biosimilars now have a regulatory pathway, but are the directions to approval clear?
The development of pharmaceuticals derived from cannabis took a major step forward in June when the UK’s Medicines and Healthcare Products Regulatory Agency approved the prescription use of Sativex to treat spasticity due to multiple sclerosis.
Industry-Academia collaborations may pay off with hESC-based drug screening advances.
Debate continues within the government and scientific communities over how best to balance the often-competing interests of security and research freedom when it comes to potential bioterror pathogens such as Bacillus anthracis and Botulinum neurotoxins.
The National Institutes of Health (NIH) has been stung in recent years by numerous reports of financial conflicts of interest involving staff scientists and drug, biotech, and medical device companies.