Jill Wechsler, ACT's Washington Correspondent

Current clinical trials are regarded as “too slow, too expensive, not reliable, and not designed to answer the important questions,” according to FDA’s new deputy commissioner for medical products &tobacco, Robert Califf.

Among the multiple proposals for stimulating drug development and revising regulatory processes, the 21st Century Cures initiative includes several provisions designed to streamline clinical research and the amount of data required to gain FDA approval of certain indications.

Demands from patient advocacy groups for broader subgroup representation in clinical trials has generated a new drug trial transparency initiative at the Center for Drug Evaluation and Research (CDER).

The productivity of the U.S. biomedical research enterprise is undergoing a broad re-examination.

Patient focused drug development is playing a larger role in study design and outcome measurement.

FDA commissioner Margaret Hamburg has received praise and plaudits as she exits the Food and Drug Administration this week after six years on the job.

Patient focused drug development (PFDD) is moving into the mainstream, promising to alter the conduct of clinical trials and FDA regulatory policies.

The ongoing battle over drug reimbursement and pricing has raised questions about whether the pharmaceutical industry can continue to rely on high U.S. revenues to fund biopharmaceutical R&D. Payers and insurers have become more aggressive in demanding clear evidence of value for high-priced medicines and are rejecting old models for coverage and reimbursement.

The "discussion draft" for legislation to speed "21st Century Cures" to patients emerged very quietly on Capitol Hill recently, muted by an absence of bipartisan support which had generated considerable enthusiasm for this effort to promote biomedical research and streamline regulation.

A surge in review activity at the FDA in December resulted in a near-record approval of 41 new drugs and biologics last year, the most since a record 56 approvals in 1996.

Agency proposes new standards in hopes of capitalizing on 2014 surge in new drug approvals.

One way to reduce off-label prescribing of treatments for cancer and other conditions is for manufacturers to test additional indications and file supplemental applications to add those uses to approved labeling

Efforts are escalating to encourage sponsors, research institutions and clinical investigators to accept oversight for multi-center studies by central Institutional Review Boards (IRBs).

Investigators and sponsors of clinical trials will have to make more detailed data available following study completion, according to a new report from an Institute of Medicine expert panel.

The main surprise at the Jan. 7, 2015 meeting of FDA’s Oncologic Drugs Advisory Committee was the panel’s strong support for a drug developed under a very different model from most cancer therapies.

FDA set several milestones in approving more new, important drugs and biologics in 2014.

Patient access to critical experimental medicines continues to grab public attention, as states enact “Right-to-Try” laws and Congress eyes establishing a national policy to provide not-yet-approved therapies to terminally ill patients.

FDA has scheduled a public meeting in early January to assess and weigh the data on the first US application for a biosimilar therapy.

Building on more than a decade of initiatives to spur pediatric labeling on drugs and biologics, regulatory authorities are bolstering incentives for sponsors to develop more information faster on the use of medicines in children.

The development and approval of new vaccines and antivirals to contain and treat the Ebola virus outbreak has become a top priority for the federal government and Congress.

PCORI is launching a $50 million program to fund research on the comparative effectiveness of various approaches for diagnosing and treating hepatitis C.

The promise is that customized delivery of injectible drugs and biologics will reduce toxicity, enhance individual response, facilitate the delivery of multiple drugs, minimize waste, and encourage patient adherence to prescribed treatment.

The two-year-old initiative to accelerate the development and approval of highly effective drugs and biologics has enabled a number of important new medicines to reach patients sooner, according to Janet Woodcock.

US researchers and regulators continue to support the use of randomized clinical trials to test potential treatments and vaccines to combat the Ebola virus...

The 2014 mid-term elections handed over control of the Senate to Republicans and boosted the GOP majority in the House.

There's a mounting campaign to encourage biopharmaceutical companies to develop new therapies to treat drug-resistant infections.

Leading Senators are proposing legislation to add Ebola to the list of diseases eligible for priority review vouchers from the FDA.

The rush is on to develop new therapies and vaccines to combat the lethal outbreak.

The federal Open Payments program went live Sept. 30.

Key differences and gaps in requirements for testing and documenting product similarity have emerged among the European Union, the US and other regions.