FDA

A first vaccine against this coronavirus could still take some time to develop, but mRNA vaccine platforms could offer an early breakthrough.

An amendment to Pediatric Research Equity Act, as part of the 2017 FDA Reauthorization Act, goes into effect soon aiming to change the landscape and promote pediatric cancer drug development.

FDA's plans to resume inspections of some US regulated facilities this week are not clear on which sites will be visited and what alternative oversight strategies will apply where on-site inspections are difficult.

The need for treatments to combat the spread of COVID-19 is promoting greater cooperation among drug regulatory authorities around the world, with FDA officials communicating more frequently with their counterparts in Europe, Canada, Japan and other nations through established programs and agreements.

The research community is moving quickly to launch clinical trials of potential countermeasures, while regulatory authorities aim to support product development through regulatory flexibility.

FDA’s new commissioner, Stephen Hahn, announced his priorities at an FDA “all hands” staff meeting last week. Jill Wechsler reports.

While not setting any records for the rapid approval of new drugs in 2019, FDA did speed a number of important new therapies to patients, writes Jill Wechsler.

FDA’s Office of New Drugs restricting aims to improve scientific exchange and information sharing among review professionals.

Examining the unique aspects involved in preparing and submitting marketing applications for proposed treatments for rare disease.

CDER's Rare Disease Cures Accelerator initiative looks to foster a coordinated research approach and methods that can expedite development of drugs to treat some of the 7,000 rare diseases.

Concerns for patient safety are raised with the recent surge in new drugs receiving fast-track FDA approval. Jill Wechsler reports.

FDA draft guidance for modernizing the approach to clinical trial design for oncology drugs and biologics look to make clinical trials more efficient while maintaining patient safety.

A new CDER “knowledge management” approach will see companies submit applications that can be transmitted to experts from multiple disciplines able to assess applications for new drugs and biologics in a timely and efficient manner.

Supporting real change in clinical trials is more than just lip service-it’s putting the information out there transparently for all stakeholders to measure and make decisions.

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

Rho offers their expertise on why it is important to have a pre-IND meeting to ensure a successful IND.

With the EU’s new General Data Protection Regulation coming into force in May this year, the impetus for life sciences firms to cement their data management strategies has increased.

An overview of all the drug approvals that were secured in 2017.

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.

The FDA published a final rule on FDA’s standards for accepting data from clinical investigations for medical devices on February 21.

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

The FDA's new draft IVD Guidelines will need to be factored into how pharma clinical trial sponsors use IVDs in a clinical trial, study design, timeline for protocol development, IND submission, and study initiation.

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.

In this interview, Austin Speier, VP of Emerging Technologies at Precision for Medicine, will elaborate on these draft guidance documents.

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