Jill Wechsler

FDA and industry see progress and challenges in bringing cutting-edge medicines to patients.

FDA and industry seek a more consistent, flexible CMC review process for breakthrough therapies.

More “me-betters” and more focused breakthroughs could enhance new drug development.

The bio/pharmaceutical industry will face increased scrutiny of product quality and cost drivers.

FDA confirmed quality focus while Congress moved to bolster biomedical innovation.

FDA seeks industry support for metrics program, emphasizing the surveillance focus.

There’s renewed optimism in the biomedical research community that years of effort finally may begin to pay off for developing cutting-edge gene and cellular treatments for debilitating and life-threatening conditions. Jill Wechsler reports.

Robert Califf addresses questions about drug pricing at the Senate hearing to weigh his appointment to be the next commissioner of FDA.

Even though rising production and use of generic pharmaceuticals is saving billions for the nation’s healthcare system, policy makers continue to slap the industry with policies it claims will limit product development and sales.

New program emphasizes quality, risk, and global collaboration.

Despite considerable investment by biotech manufacturers in developing competitive biologics for the US market, gaining FDA approval of these products has turned out to be a slow and complex process.

In testifying before Congress on FDA regulation of long-awaited biosimilars, Janet Woodcock emphasized the importance of ensuring that the evaluation of new therapies is based on sound science.

The White House nominates Robert Califf to head FDA, but will he be confirmed?

Manufacturers challenge details in new policies designed to promote access to important therapies.

Legislation to streamline drug development may get tangled up in user fee negotiations and drug pricing battles.

Manufacturers seek gradual rollout of more targeted FDA quality metrics program.

The Reagan-Udall Foundation for the FDA (RUF) is overcoming initial roadblocks and gaining support from a range of public and private organizations.

Regulatory officials and industry scientists participated in a CMC Strategy Forum sponsored by CASSS in July 2015.

FDA and industry support global framework and collaborations to secure the supply chain.

The broader aim of FDA's metrics initiative is to encourage quality manufacturing operations that will help avoid drug shortages.

Manufacturers are producing new drugs and vaccines and clinical supplies faster and more efficiently through the development of standards and common practices for single-use technology systems.

A year-long process reauthorizing the Prescription Drug User Fee Act was launched July 15, 2015 with a public meeting, setting the stage for discussions with industry and FDA.

The 21st Century Cures Act took a giant step forward with a 344-77 approval in the House; the Senate debate is still ahead.

Manufacturers and FDA look for innovative strategies to meet accelerated timeframes.

FDA recently issued a much-anticipated draft guidance on how to define and report established conditions in market applications.

Drug quality issues have forced the National Institutes of Health to shutter its in-house facility for producing clinical supplies for certain clinical trials.

Regulators and industry seek to streamline and harmonize oversight of postapproval changes.

Widespread use and abuse of opioid painkillers is prompting efforts to develop new drugs and formulations that resist abuse while providing relief to legitimate patients.

The House Energy Committee’s approval of the 21st Century Cures legislation is only a first step, with critics and collaborators alike lining up to comment.

As the biopharma industry awaits FDA’s guidance on biosimilar naming, brand and generic manufacturers establish positions.