Jill Wechsler, Pharm Exec’s Washington Correspondent

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

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

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

FDA's opiod REMS implies there is still value in industry-sponsored CME

Stiff price tags draw scrutiny from Congress and consumers, and raise questions about FDA policies

Courts, Congress review policies and programs shaping drug costs and access

FDA's Sentinel Initiative raises broader questions about tapping patient information and health IT for comparative studies in drug development

Pharma companies will assess health reform, negotiate user fees and keep an eye on federal prosecutors in the year ahead

Health reform requires detailed tracking and full disclosure of fees to docs for marketing and research

FDA seeks to regulate genetic tests more actively, while encouraging diagnostic development

Drug prices, doctor payments, and FDA regulatory decisions are candidates for expanded disclosure.

Under the new healthcare regime, pharma will ante up fees and rebates in return for expanded sales and safeguards.

FDA Commissioner Margaret Hamburg looks to bolster the agency's scientific expertise.

FDA's new Sentinel System is going live, but the signals may be difficult to assess.

Added funds for FDA to come from new user fees, largely for food and tobacco regulation.

R&D is surging, but new methods and data raise new manufacturing and regulatory challenges.

They already dominate the pharmaceutical market, and now generics are poised to move into biologics and complex dosage forms.

FDA and Congress weigh policies for improving drug safety via ads and written information.

All the focus on drug safety raises concerns about FDA delays in approving new drugs for market.

Pharma steps up development of new vaccines and treatments to combat Third World diseases

Collins seeks to parlay genomic discoveries into new biomedical therapies. Comparative effectiveness research, he says, should identify subpopulation responses to treatment and support personalized medicine.

As FDA looks to balance risks and benefits, more regulations are on the horizon.

Marketers fear a Catch-22 if they have to write research summaries that FDA considers illegal promotion.

In addition to overhauling healthcare, Congress is weighing proposals for updating FDA policies and expanding access to drugs.

The latest buzzword in pharma is "transparency"

A close look at the healthcare industry will separate real cost-cutting measures from money-saving myths.

Will more resourches and new leadership fix FDA, or is a major overhaul in order?

As Congress moves to curb industry influence, support for med ed is waning

Congressional leaders ready campaign to curb Medicare drug plans.

FDA missteps and global outsourcing are drawing Congressional scrutiny and prompting new oversight approaches