Regulatory

March 15, 2017

Trump’s choice for FDA commissioner faces drug pricing, regulatory, and approval challenges.

Thomas Christensen outlines some of his lessons learned for first time OPDP submissions, promotional material, and labelling.

March 10, 2017

Rare Disease Day is a good moment to sound a warning that providers of rare medicines may be the next to land in the hot seat, writes Meg Alexander.

An FDA Memo addressing First Amendment legal issues regarding off-label use of medical products falls short of the necessary clarity, write Jamie Kendall and Alexandra Schulz.

Attack on treaties and imports threatens international operations.

President Trump calls for faster FDA approvals and lower drug prices. Jill Wechsler reports.

Brooke Ringel and Eric McClafferty outline steps companies should take to ensure compliance with export controls.

February 17, 2017

In promising to expedite and simplify the FDA approval process, Donald Trump fails to take account of industry's appreciation an efficient, rigorous FDA regulatory system, writes Jill Wechsler.

Congress is poised to tackle exorbitant drug prices through health reform and FDA legislation.

Ruth Trzcienski's reviews FDA's new Procedural Guidance to help manufacturers ensure consistency with the FDA-required labelling.

Pharm Exec speaks to ICON's Ramita Tandon about how the UK and European regulators' market access plans for 2017 will affect the industry.

Rethinking views on limited-efficacy drug approvals may be in order.

Health reform, pricing pressures will shape drug marketing and development in 2017, writes Jill Wechsler.

The long-cherished dream of finding a European approach to assessing the value of new medicines seems to recede further with every step taken to pursue it, writes Reflector.

Health reform, pricing pressures will shape drug marketing and development in 2017.

2016 has been the year of the unpredictable - and the uncertainties this has generated will multiply and dominate the agenda in Europe in 2017, writes Reflector.

Congress's enactment of 21st Century Cures legislation may have given pharmaceutical manufacturers an early Christmas present, but some concerns are being voiced, writes Jill Wechsler.

Republican control of Washington promises overhaul of healthcare and medical product regulation.

Significant uncertainty surrounds the future of drug pricing reform, causing industry observers to take a closer look at the policy views of the president-elect, state and Congressional lawmakers, and the general public.

Congress took a major step yesterday towards shoring up FDA operations and biomedical research supported by the National Institutes of Health with House passage of the 21st Century Cures bill.

The FDA’s Dr. John Whyte offers his perspectives on patient centricity and the issues that FDA and industry are facing.

Biosimilars are gaining more support among payers and physicians, but more needs to be done to explain their benefits as well as their safety and efficacy profiles, writes Barbara Testa.

The European Medicine Association is determined keep open all options on the future of drug approvals in advance of a crucial meeting in December, writes Peter O'Donnell.

Biopharma companies should no longer consider FDA an obstacle to innovation and in need of major reform, according to Jim Greenwood, President of BIO.

The surprise victory of Donald Trump opens the door to new strategies for providing healthcare to Americans, including coverage and oversight of prescription drugs.

FDA officials agree that large comparative clinical trials defeat the purpose of the abbreviated development program for biosimilars.

Policymakers, payers and pharma companies weigh strategies for rationalizing drug prices . Jill Wechsler reports.