Regulatory

The Reagan-Udall Foundation for the FDA (RUF) is overcoming initial roadblocks and gaining support from a range of public and private organizations, writes Jill Wechsler.

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 move towards centralizaton and harmonization means that the regulatoy and pharamcovigilance functions can longer work independently, writes Markus Dehnhardt, Ph.D.

FDA needs to expand and empower its Office of Health & Constituent Affairs (OHCA) and its Patient Liaison Program to better coordinate interactions with individuals and physicians seeking expedited access to experimental therapies

As the case decades ago, the “drug line” continues to be a major, if not the primary, concern of Medicaid administrators across the nation.

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

Come fall, Boeing employees in St. Louis and South Carolina will get a new coverage alternatives in addition to their Blue Cross and Blue Shield plans.

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.

The biosimilars market forecaster must create a framework that captures the dynamics that operate in these markets and do justice to the uncertainty and quantification of assumptions, writes Arthur G. Cook

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

Jill Wechsler cast her eye over FDA acting commissioner Stephen Ostroff's international plans.

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.

Bryan Spielman outlines why China is poised for a data renaissance-one that could play a pivotal role in the next wave of pharma innovation.

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.

BioPharm International speaks to the United States Pharmacopeial Convention to find out who will truly have the final say when it comes to biosimilar nomenclature.

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.

The House Energy & Commerce (E&C) Committee unanimously approved the 21st Century Cures legislation last week, but the debate is slated to continue for several months, if not longer. Jill Wechsler reports.

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