Jill Wechsler, Pharm Exec’s Washington Correspondent

The Three Cs could be taxing on FDA resources as the new Congress brings stiffer oversight and leadership revisions to the agency

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.

FDA and industry seek to ensure drug quality in a world complicated by global outsourcing and theft.

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.

FDA Commissioner Margaret Hamburg has a history of health advocacy and a clear mandate to transform the agency. But can she succeed where others have failed?

Pharma must confront regulatory and marketing challenges in a global competitive environment.

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

House bill boosts rebates and opens the door to government price negotiations.

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

Pressure to expand healthcare puts drug pricing, marketing, and innovation on the negotiating table.

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.

FDA is seeking more resources to support compliance and oversight.

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

Pharma fears comparative effectiveness research will focus on costs and stymie personalized medicine.

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?

To expand health coverage amid an economic crisis, Obama will be looking hard for ways to cut costs

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