Jill Wechsler, ACT's Washington Correspondent

FDA Commissioner Scott Gottlieb supports approaches that help biomedical research “become more agile and efficient” and reduce the cost of developing therapies, including decentralized trials and how real world data (RWD) and real world evidence (RWE) to support a range of drug development goals.

FDA prioritizes to maintain, and continue to improve, the efficient and effective drug development and review system the agency has established in recent years.

To further streamline product development and facilitate post market safety surveillance, the agency has developed a new Framework for Real-World Evidence that spells out opportunities and concerns in advancing these approaches.

New FDA guidances outlining recommended approaches for clinical testing methods and collecting research data, alongside with public workshops and meetings, accelerate reviews to speed new therapies to market.

FDA initiatives aim to increase biomarkers and early advice to sponsors for more efficient and cost-effective clinical trials for developing targeted therapies, including orphan therapies.

As FDA continues to advance the role of patients in designing clinical trials with meaningful and accurate endpoints, it is seeking more input from stakeholders on how best to identify clinical outcomes most important to patients and caregivers.

FDA is joining with other federal health agencies and the biomedical community to advance science, regulatory policies, and reimbursement strategies to combat the need for new medicines for infectious diseases.

The critical need for new medicines to combat infectious diseases is prompting FDA to join with other federal health agencies and the biomedical research community to advance the science, regulatory policies, and reimbursement strategies to promote innovation in this area.

To help combat the nation’s opioid epidemic, FDA is promoting a more tailored approach to developing and testing effective analgesics, with the aim of bringing less addictive pain treatments to market more quickly.

Jill Wechsler details new FDA policies to streamline drug development, including the design of “seamless” trials.

As part of efforts to speed patient access to effective new therapies, FDA is rolling out policies designed to streamline drug development, particularly for new cancer therapies to treat life-threatening conditions.

The potential for innovative gene therapies to treat and even cure a range of serious diseases is prompting FDA to ramp up support for developing and testing new products efficiently and effectively.

FDA is testing various strategies to streamline research and regulatory oversight by looking to novel clinical trial designs to advance new treatments.

Jill Wechsler details the continued rise of incorporating the “patient experience” in drug development measures.

Right-to-Try bill sent to White House for President’s signature after passage by Congress.

Jill Wechsler interviews FDA Commissioner Scott Gottlieb about his push for more efficient R&D to help lower drug prices.

Recent legislation authorizes further assessment of FDA eligibility policies and of NIH research standards.

Jill Wechsler on the tug of war in accelerating orphan drug development.

To encourage experimentation with more complex clinical trial strategies, FDA plans to launch a pilot program to assess complex studies proposed by sponsors.

Under pressure to meet tight deadlines for reviewing and approving a growing volume of applications for new drugs, generics, and medical products, FDA is rejecting submissions that are incomplete or unsatisfactory right from the start.

Jill Wechsler details the two chief reasons why clinical trial quality and efficiency has improved in recent years.

FDA funding increased under Trump's budget for 2019 fiscal year while resource reductions take place for NIH.

The 10th anniversary of the Clinical Trials Transformative Initiative provided an opportunity for FDA officials to join with study sponsors and research experts to examine the policy achievements and plans for future efforts of improving clinical trials.

Now the challenge to FDA and to sponsors is to maintain the high level of support for research, discovery, and regulatory flexibility underpinning these gains, writes Jill Wechsler.

Investigators aim to increase the efficiency and consistency of FDA’s Bioresearch Monitoring program.

The agency is moving to smooth the pathways for orphan drugs, genetic therapies, and other scientific advances to yield more transformative medicines.

Jill Wechsler talks about biosimilars and the requirement of clinical trials in her recent blog.

FDA advisory committee made up of patients comes together to improve clinical trials and product development through better study design and greater participation.

Most physicians and many specialists have limited understanding of clinical trial data and research findings presented in prescription drug promotional materials for professional audiences.

New legislation aims to expand regulatory acceptance of patient data from healthcare systems and observational studies.