FDA

The majority of pregnant women are prescribed treatments that can include antibiotics, antivirals and more. However, little to no information is available about the appropriate dose to prescribe or the potential adverse fetal effects.

Policy makers, sponsors and regulators are taking steps to promote alternative study formats and methods that go beyond randomized clinical trials.

The Senate confirms Scott Gottlieb as FDA commissioner. User fee reauthorizations, a hiring freeze, and the opioid epidemic are a few of the issues awaiting the agency's new leader.

This article describes the experiences of the Medical University of Vienna with the Directive 2001/20/EC (CTD) regarding academic clinical research and reflects on the changes introduced by the Regulation (EU) 536/2014 (CTR).

The new law on research in France introduces changes for the medical device industry by facilitating the conduct of postmarketing studies. Devices will no longer have to be provided free of charge for low-risk interventional studies making France a possible location for such trials in the future.

At his confirmation hearing before the Senate Health, Education, Labor and Pensions Committee, Scott Gottlieb addressed concerns about the FDA’s future.

For several decades, life sciences companies’ clinical development of products has focused predominantly on efficacy and specific mechanisms of action to drive efficacy forward. But as competitive pressures intensify and demands by patients and regulators for better-tolerated drugs increase, progressive companies are exploring safety as a product differentiator during the clinical trial process. Cheryl Key explores that development.

President Trump’s nomination of Scott Gottlieb as the next FDA Commissioner has given pharma a reason for calm, though a lot will be on his plate.

Patient advocates are witnessing a shift in the culture of drug development as sponsors and regulatory agencies show more interest in incorporating patient perspectives.

Pressure from the FDA and Congress has resulted in sponsors enrolling more women, elderly and ethnically diverse individuals in clinical studies.

FDA bioresearch monitoring staffs are being prompted to update and refine systems for targeting inspections to key study sites.

The needed resources to implement "Cures" legislation makes it critical that user fee programs for drugs are reauthorized well before they expire on Sept. 30.

The FDA has released a report that documents the value of large, confirmatory Phase III studies in ensuring the safety and efficacy of experimental medical products.

Congress took a major step yesterday towards shoring up FDA operations and biomedical research supported by the National Institutes of Health with House passage of the 21st Century Cures bill.

For those still waiting, the time is now to get compliant on FDA's new data submission requirement.

As the discussion on patient centricity continues, industry personnel are attempting to further define the concept. John Whyte of the FDA sits down with us to explain his perspectives and experiences on the subject.

The FDA approved Sarepta’s Exondys for Duchenne muscular dystrophy despite little evidence of efficacy, leading many to regard the decision as not being a model for future drug development. The challenge now is to see if confirmatory trials show more benefit, or lack of efficacy.

The deadline looms for new FDA requirements that all applications for new drugs and biologics compile and submit clinical trial data electronically. Meanwhile, efforts by the Clinical Data Interchange Standards Consortium (CDISC) to develop consensus-based standards for collecting data are not going unnoticed.

FDA and industry have agreed on a set of recommendations for revising the drug user fee program, which now sits before Congress as U.S. election nears.

The FDA’s objectives regarding pediatric labeling have been misunderstood due to a confusing history on the matter. Data extrapolation can leverage an avenue for providing more comprehensive labeling for pediatric drugs.

Processes for collecting data of serious adverse events (SAEs) and events of special interest (ESI) during clinical trials have been underwhelming for sponsors. Improving these processes using the latest digital advances can result in more complete analyses and more effective decision-making.

Clinical trial noncompliance has always been an industry concern. According to the FDA, the most common compliance deficiencies during inspections include inadequate investigator oversight, protocol deviations, poor record keeping, insufficient investigational product accountability, and issues with subject protection and consenting1.

The need to revise the design, performance and interpretation of clinical research to reflect changing methods and standards is drawing increased attention.

In response to the debate over allowing patients timely access to new therapies and ensuring safety, the EMA launched the PRIority MEdicines (PRIME) scheme in March. The aim of this initiative is to build upon existing regulations in Europe to support product development in cases of unmet medical need.

FDA's breakthrough drug initiative has proven successful to date, but challenges remain in addressing the expectations and patient concerns surrounding candidates in this program.