The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) recently issued two revised documents for its Manual of Policies and Procedures (MAPP): one addresses updated procedures for its data standards program and the other covers operational procedures for scientific interest groups (SIG).   The 10-page MAPP on data standards governance discusses the operating model to support the implementation of CDER’s data standards program. It r...

In a move toward more transparency, the US Food and Drug Administration (FDA) on Friday announced it would publicly disclose the unredacted curricula vitae (CVs) of advisory committee members. A consent form saying the member’s CV does not include any confidential information will need to be submitted, FDA said. Background FDA maintains about 50 advisory committees comprised of outside experts who weigh in on scientific and medical issues, and which typically convene ...

The controversial US Food and Drug Administration (FDA) approval last year of the first drug intended to treat women bothered by a lower sex drive has opened the door for other companies to develop similar drugs. Now, FDA is trying to clarify what these drug developers racing to create the next female Viagra should focus on, with particular discussion of the challenges involved, including diagnostic criteria, endpoints and patient-reported outcome (PRO) instruments. Th...

The US Food and Drug Administration (FDA) on Monday announced it is awarding $23 million in research grants for 21 new clinical trials over the next four years to boost the development of rare disease treatments. The grants, awarded to researchers from academia and industry at domestic and international clinical sites, are part of FDA’s Orphan Products Clinical Trials Grants Program, created in 1983, which has provided more than $370 million (including $19 million ...

A new analysis published in The BMJ finds that more than a quarter of hematology and oncology drug reviewers at the US Food and Drug Administration (FDA) left the agency to work or consult for the biopharmaceutical industry between 2001 and 2010. "We are concerned by these findings," write Dr. Vinay Prasad and his colleague Dr. Jeffrey Bien at the Oregon Health & Science University, "The transition from regulator to advising companies seems logical but it raises questi...

The US Food and Drug Administration (FDA) on Tuesday issued a new draft guidance detailing its approach to determining whether advisory committee members can participate in decisions when the appearance of a conflict might signal an actual conflict of interest. FDA maintains around 50 advisory committees, comprised of experts from outside the agency, to weigh in on specific scientific and medical issues. These committees are typically convened when FDA wants input on a n...

The US Food and Drug Administration (FDA) has granted a waiver to allow the chairman of its Circulatory System Devices advisory panel to keep his position later this month despite a conflict of interest. Richard Page, chair of the Department of Medicine at the University of Wisconsin School of Medicine and Public Health, currently serves as chairman of the Circulatory System Devices advisory committee, which reviews and evaluates data concerning the safety and effective...

The US Food and Drug Administration (FDA) on Tuesday released a warning letter to Monmouth Medical Center, a New Jersey hospital, after an inspection of its institutional review board (IRB) found it failed to follow regulations meant to protect clinical trial participants, including for pediatric studies. Specifically, the IRB failed to adequately document whether clinical investigations involving pediatric subjects were in compliance with FDA regulations, or document wh...

Pharmaceutical companies concerned by US Food and Drug Administration (FDA) actions or decisions have a number of informal and formal ways to get in touch with and file appeals with the agency, two FDA officials told attendees at RAPS’ Regulatory Convergence last month. The conversation on disputes came as FDA in September further clarified and updated its guidance on how it resolves complicated medical and scientific disagreements between industry and FDA. Informal D...

A coalition of health advocacy groups are worried that too much of the European Medicines Agency's (EMA) funding comes from private industry. Background Much like the US Food and Drug Administration (FDA), EMA receives much of its funding from fees it collects from industry for various services, such as application fees, scientific advice and pharmacovigilance fees. Generally, industry has been supportive of regulators charging fees for these services (although somet...

Members of scientific and expert committees at the European Medicines Agency (EMA) will no longer be able to take part in the evaluation of medicines if they intend to work for a pharmaceutical company. Background In 2012, EMA came under fire from the European Court of Auditors (ECA), after an audit uncovered a number of shortfalls in the agency's conflict of interest (COI) policies. At the time, ECA made recommendations to EMA intended to improve the agency's CO...

If you have an idea for what the US Food and Drug Administration's (FDA) pharmaceutical regulators should be working on, now is the time to speak up. In a Federal Register announcement on 19 March 2015, FDA said it "hopes to foster collaborations with external partners and stakeholders" to help address a long list of regulatory "needs and priorities" identified by its Center for Drug Evaluation and Research (CDER), which is in charge of regulating drug products. The...