Regulatory

A non-antibiotic bactericidal treatment for humans was first proven effective in 1919. Ansis Helmanis asks why they are not commercially available in the United States.

France's bid to regain its influence reveals how far Europe is from fully achieving regulatory convergence, writes Reflector.

Manufacturers seek gradual rollout of more targeted FDA quality metrics program.

The case of Amgen v. Sandoz signals that preliminary injunctions will play major role in future patent disputes

FDA reform may get tangled up in user fee negotiations, budget debate

With biopharma companies increasingly accused of bankrupting the health care system with high prices, news that ICER has received a $5.2 million grant to expand its analyses of drug cost-effectiveness could be a game changer, writes Jill Wechsler.

For the second time in three years, the Supreme Court of the United States (SCOTUS) has weighed in on key aspects of the 2010 Obamacare law. Tom Norton reports.

Lisa Henderson discusses how role of social media in post-market adverse event reporting is finally being taken seriously by the FDA.

FDA has launched the process for reauthorizing the Prescription Drug User Fee Act (PDUFA), setting the stage for FDA to hear the views of patient, consumer and health professional representatives. Jill Wechsler reports.

The budget increase for NIH brought strong support from the biomedical research community and medical societies across the board.

All indications are that the July 2016 deadline for transition from Europe's eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) to the new Identification of Medicinal Products (IDMP) is not achievable. Sophie Daniels reports.

Despite recent advances, there continue to be significant issues that compromise the effective management of pulmonary arterial hypertension, writes Victoria Allan.

FDA wants pharma to be more selective in seeking special status for promising therapies

Drug quality issues have forced the National Institutes of Health to shutter its in-house facility for producing clinical supplies for certain clinical trials.

For the 17 states that set up their own state exchanges under Obamacare, finding ways to manage a couple aspects of the new law are turning 2015 into a “Year of Harsh Realities.” Tom Norton explains why.

New proposals from Congress to spur innovation will strain resources needed for regulatory approval, writes Jill Wechsler.

New proposals from Congress to spur innovation will strain resources needed for regulatory approval.

Widespread use and abuse of opioid painkillers is prompting efforts to develop new drugs and formulations that resist abuse while providing relief to legitimate patients, writes Jill Wechsler.

A hot commodity, the FDA’s Rare Pediatric Disease Priority Review Voucher program once again proved its worth, with today’s $245m transaction.

After hearing “strong views” on the issue, FDA is expected to release biosimilar-naming guidance later this year.

Current clinical trials are regarded as “too slow, too expensive, not reliable, and not designed to answer the important questions,” according to FDA’s new deputy commissioner for medical products &tobacco, Robert Califf.

The House Energy and Commerce Committee gave unanimous approval to the landmark 21st Century Cures Act reform bill on May 21, 2015.

EUnetHTA has developed guidelines to help “set a general framework for EUnetHTA on how to conduct economic evaluations”, arguably HTA's most controversial element. Leela Barham reports.

Edging through the complex terrain that is health technology assessment in Europe

The revised Cures proposal makes it easier for pharma to distribute journal articles and medical textbooks to physicians, but it also drops provisions that provided added exclusivity for certain new therapies.