Regulatory

More generics and biosimilars may generate competition - but FDA opposes broad compounding, writes Jill Wechsler.

President Obama’s year-old, $200 million Precision Medicine initiative (PMI) seems to be doing exactly what was intended, writes Heather Gartman.

Clinical trials are challenging because pain is subjective, making it hard to define objective endpoints or to compare one drug to another.

Various factors have altered the landscape for exchange of information on drugs and medical products, but the FDA has not kept pace in updating its rules governing what marketers can say about their therapies, writes Jill Wechsler.

FDA needs to make major changes in how it evaluates R&D of new combination therapies for cancer and other serious conditions, say patient advocates, cancer specialists and biopharma companies.

After eight years in development, FDA is looking to expand its Sentinel system to play a more visible role in assessing medical product efficacy, as well as safety.

Arvind Mani and Sherry O' Quinn outline the prevalence of private payer PLAs in Canada.

There was scant praise from the medical community for the eighth and final budget plan from the Obama administration.

Valeant and Turing's fuzzy explanations of pricing practices to the House Oversight and Government Reform Committee cast a shadow over the broader industry, writes Jill Wechsler.

As that nation heads towards its first presidential primaries of the 2016 election, pharmaceutical executives should take a few minutes to consider where the leading candidates stand on U.S. Rx policy. Tom Norton takes a look.

More oversight of regulatory programs and policies planned by GOP critics.

GOP critics of the Agency are planning more oversight of regulatory programs and policies. Jill Wechsler reports.

It’s easy to foresee controversy in 2016 as lagging global economic growth and a messy US political slugfest force the pharma industry’s feet to the fire. Can the industry reclaim a semblance of public approval by confronting its pricing demons and focusing on innovation and a fresh, patient-first message?

The changing tides in the global healthcare market are showing no signs of letting up. Here's my take on the opportunities, threats, and other big issues facing the industry in the new year.

Jill Wechsler reports on how FDA is trying to finding a balance between clinical trials large enough to assess all relevant populations and small enough to include deep data on each patient.

While the 1984 Act has been a boon for lower-cost generics, its goal of incentivizing new drug discovery has failed.

Cures remain elusive, but regulators and industry are building ties that bind.

The last few months have been tough for pharmaceutical companies, and the political environment in Washington isn’t likely to improve in the coming year, writes Jill Wechsler.

OND Director John Jenkins would like to see sponsors invest in more “me-better” drugs-as opposed to “me-too” medicines-to expand treatment options for patients and to boost competition among manufacturers.

Jill Wechsler on why the FDA program that encourages biopharma companies to develop new treatments for rare and neglected diseases has been in the spotlight recently.

December 18, 2015.

Janet Woodcock, director of the Center for Drug Evaluation, highlights FDA's priority list for 2016.

Drug pricing backlash threatens regulatory reform, R&D advances

December 07, 2015.

December 02, 2015.

In the last year regulatory authorities sharpened their focus on gathering more data and on achieving transparency and harmonization. Erick Gaussens reviews 2015 and looks at companies’ need to respond to converging demands in 2016.

The Parliamentary Assembly of the Council of Europe is the latest to clamber aboard the well-filled bandwagon now rumbling and rattling across Europe in an increasingly noisy debate over drug prices. Reflector reports.

There’s renewed optimism in the biomedical research community that years of effort finally may begin to pay off for developing cutting-edge gene and cellular treatments for debilitating and life-threatening conditions. Jill Wechsler reports.

The Senate hearing to weigh the appointment of Robert Califf to be the next commissioner of FDA was a fairly friendly event, with mostly softball questions about policies and programs. Jill Wechsler reports.

November 18, 2015.