Jill Wechsler, ACT's Washington Correspondent

FDA commissioner Margaret Hamburg has formed a top-level working group to propose strategies for enhancing agency functions and processes, starting with the relationship between FDA Centers and its field force.

There are signs of trouble in the latest announcement of user fees for 2014 authorized by the Prescription Drug User Fee Act (PDUFA).

We?re already embroiled in the annual speculation game about whether FDA approvals this year will keep pace with last year?s near-record of 39 new molecular entities (NMEs) brought to market.

Everyone is looking to rev up the biopharmaceutical development pipeline, and the FDA is working hard to do its part.

A consortium of leading biopharmaceutical companies is moving forward with several projects to make clinical trials more efficient and less costly.

The Supreme Court decision blocking patents on naturally-occurring genes has generated predictions of doom for biotech innovation, along with expectations of more healthy competition in discovering new treatments and diagnostics.

Food and Drug Administration officials are busy implementing its provisions that offer new approaches to clinical trial design and application review.

There is great optimism that new genomic discoveries and technical advances will reduce the cost and time of moving important new therapies for cancer and other critical diseases from laboratory to patients.

In recent documents and presentations, officials in the OSI in the CDER are highlighting the value of building quality into the design and operation of clinical trials to gain more efficient and effective monitoring and data verification systems.

The long wait is finally over for muchanticipated regulations governing disclosure of pharmaceutical company payments to physicians, and on the rights of patients to protect access to their personal health information (PHI).

The Food and Drug Administration approved nearly 40 new drugs in 2012, beating most recent totals, and is looking for provisions of the FDA Safety & Innovation Act (FDASIA) to further improve its operations and encourage innovation.

Intense pressure to streamline the drug development process by making clinical research more efficient is prompting a wave of joint initiatives among pharmaceutical companies, government agencies, and academic medical centers.

The end of the highly acrimonious election campaign has signaled a shift by policy-makers and interest groups to focus on dealing with the so-called government "fiscal cliff."

The key to accelerating drug development, according to numerous experts, is to revise requirements that generate lengthy, complex, and costly clinical trials.

To fully utilize the great advances in understanding the genomic basis of disease, clinicians need medical diagnostics able to identify those individuals most likely to benefit from pharmaceutical therapy, and those at risk for adverse events.

Even though thousands of clinical trials are listed on public websites, and sponsors are posting results from more key studies, consumer advocates continue to press for broader public disclosure of information on research involving human subjects.

The main result of the Supreme Court decision upholding the Affordable Care Act (ACA) is that it ends all the rampant speculation and uncertainty about the future shape of the US healthcare system.

It's hard enough to conduct clinical trials for experimental medicines, but it can be even more difficult when patients already have access to the medicine outside the research setting.