Jill Wechsler, ACT's Washington Correspondent

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

Consumer groups, research organizations, and Congress are pressing for more inclusive clinical research.

After months of speculation about prospects for biosimilar development in the US, Novartis announced July 24 that FDA has accepted Sandoz' biologics license application ...

A potential treatment for sickle cell disease has come through early stage development due to support from a collaborative partnership established by NCATS at the NIH.

Key to accelerating the discovery and development of new medical therapies is to improve the clinical research process.

The mounting outrage over exorbitant prices for new medicines increases the importance of reducing the cost of biomedical product development.

Congressional leaders have launched a major initiative to revise laws and regulatory policies to speed new cures to patients.

Amidst all the talk about reducing the time and scope of clinical trials to accelerate drug testing and approval, medical product development still requires researchers and regulators to "get the right answer".

A national publicity campaign recently succeeded in obtaining early access to an experimental treatment for a seriously ill child, touching off a broader discussion of compassionate use policies and their impact on drug development and approval.

A number of top management positions at the Center for Drug Evaluation and Research need to be filled...

Despite guidances and rules advising sponsors to include all demographic groups in clinical trials, many subgroups remain underrepresented.

As payers demand more evidence documenting medical product value, biopharma companies are responding by moving sooner to decide key clinical outcomes to measure.

The shift to personalized medicine has been hindered by uncertainty over the value, accuracy, and clinical utility of companion diagnostic tests.

Biopharmaceutical companies are treading lightly in the use of websites, chat rooms, and interactive online communications to support clinical research programs.

Pharmaceutical companies are jumping on the clinical trial transparency bandwagon, while also seeking to protect confidential information.

Despite a slight boost in funding for the Food and Drug Administration and stronger tax incentives for investment in R&D, significant changes in Medicare drug reimbursement and coverage policies have biopharmaceutical companies up in arms.

ROI from clinical research can suffer when too many research organizations seek to develop treatments for similar conditions and indications

PCORI is launching new programs that are expected to encourage more analysis of the effectiveness of specific drugs and medical products...

The FDA plans to issue numerous draft and final guidances in the coming months...

The Washington health policy world is headed for a major shake-up next year, as more long-time leading legislators opt for retirement.

The decline in important new medicines reaching market in 2013 has produced multiple proposals for making clinical trials more effective and efficient.

After two years in budget limbo, Congress finally enacted federal spending legislation for fiscal year 2014 last week, just before the latest funding extension ran out.

As expected, the Food and Drug Administration approved only 27 new molecular entities (NMEs) in 2013.

The shift to personalized medicine has begun to account for a greater portion of new therapies in pharmaceutical pipelines, and the biomedical research community is watching to see if this trend continues in the coming months.

Innovative uses of social media and other new information technology has become increasingly important in improving clinical research operations and sponsor communications with sites, investigators and vendors.

Ease of use, and clear directions and labeling can improve patient satisfaction with participating in a study and enhance compliance, says new ISPE survey.

The bacterial meningitis outbreak at Princeton University in recent weeks has raised questions about why there is no vaccine in US to prevent this deadly disease, when such a therapy is approved in Europe and Australia.

Policies to widen access to patient level data from clinical trials are gaining traction, despite strong opposition from research sponsors that such initiatives will undermine patient privacy and incentives for new drug development.

Officials from the Food and Drug Administration and the National Institutes of Health were scheduled to explain developments in clinical trial registration and transparency at the Drug Information Association?s conference on Clinical Trial Disclosure in Bethesda, Md. this week.

Pharmaceutical and medical products companies started to collect data on payments and "items of value" provided to teaching hospitals and physicians, as required by the Sunshine provisions.