Regulatory

Legislation fails to establish a national track-and-trace system, but tackles shortages, orphans. House and Senate leaders announced final agreement June 18, 2012 on legislation that authorizes industry user fees to support Food and Drug Administration regulatory programs.

A recent medical device controversy in France has pushed European health ministers to agree on a crisis management program for the troubled sector.

No matter how the Supreme Court rules on healthcare reform, the accountable care model will stick around. To play ball with ACOs, drug companies will need to throw a different pitch.

A rash of "pro-innovative" approaches for testing and regulating medical products offer ways to speed more new products to market.

Legislation to reauthorize Food and Drug Administration user fee programs sailed through the House and Senate last month, setting the stage for leading legislators to resolve their differences and agree on a compromise measure.

Switching Rx drugs to OTC and adding comparative data could broaden access to treatment, writes Jill Wechsler.

To gain market access in emerging markets, pharma companies face pressure to offer a convincing Corporate Value Proposition to governments.

The Supreme Court's Decision on whether pharma sales reps should qualify for the 'outside sales exemption' could have far reaching implications, write Lisa A. Schreter and Kimberly J. Gost.

Disclosure rules the day, as industry confronts demands to report supply problems, results of clinical trials, and payment to doctors.

While regulatory frameworks and medical practices differ between countries, many patients still need early access to new drugs. Industry can help.

How can we better balance addressing medical needs with ensuring that new drugs are safe and effective? Ron Cohen reports.

Our annual press audit finds that the big news in 2011 for pharma was ... no news.

FDA and industry are pushing user fees, while they struggle with curbs on communications.

Guido Rasi, the European Medicine Association's new executive director, faces many challenges, says Reflector, not least shaking off the legacy of his early predecessor, Duilio Poggiolini.

The Patient Protection and Affordable Care Act (?PPACA?) requires manufacturers to record, aggregate and report to the federal government ?payments and other transfers of value? to a covered recipient. This article will focus on the two key convention-related items under PPACA: food and educational products.

Last week, FDA Commissioner Margaret A. Hamburg testified before the House Committee on Energy and Commerce, Subcommittee on Health to outline the agency’s case for supporting the fifth authorization of the Prescription Drug User Fee Act (PDUFA), also known as PDUFA V.

After two years of waiting, FDA issued the first in a series of planned guidelines on social media at the end of last year. We look at some of the experts' reactions.

Will expanded markets and ACOs offset higher rebates, added fees, and closer scrutiny of marketing and prices?

Time to stop and think about CMS's 'Proposed Rule' on transparency and what it means for the life sciences business model.

Look for action in 2012 on drug access, shortages, innovation, and transparency.

A key consideration under the Affordable Care Act is how states select plans for drug coverage.

Agency expansion and globalization promote innovation, collaboration, and organizational changes

Thorough risk assessment is essential before placing bets on good evidence that clears a path to approval.

With OTCs challenging traditional approaches to quality, new opportunities are arising to support industry innovation and advance public health.

Clamor for critical therapies prompts probes of prices, production practices.

Janet Woodcock, MD, Director, FDA Center for Drug Evaluation and Research

Sir Michael Rawlins, Chairman of the UK National Institute for Health and Clinical Excellence

User-fee renewal legislation sets the stage for new policies affecting reimbursement, research, and regulatory oversight.

No one doubts the importance of health expenditures ? but then, euros, like dollars, don't grow on trees

A number of important decisions from the Supreme Court will affect drug marketing, research, and regulation