FDA

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.

The need to involve regulators is crucial when the use of electronic data devices impacts the management of patient safety and evaluation of trial endpoints.

Issues concerning the drug approval process in India have occurred in clinical studies resulting in a reduced interest from sponsors. The Drug Controller General of India (DCGI) has been working to amend and update it’s policies to stimulate growth in this sector.

While thousands of hours are spent in the hopes of finding more effective treatments, many of them are rejected due to administrative errors. These three tips can help reduce the frequency of common administrative mistakes during clinical trials.

The FDA’s breakthrough drug initiative is accelerating clinical development of new therapies. A recent analysis found that pre-market development time for breakthrough-designated drugs is 2.2 years shorter than for those without the designation.

FDA's new commissioner advocates for a "learning healthcare system" and less-complex clinical trial models that tap efficiencies in study design and enrollment.

Agency is asking sponsors to propose demonstration projects that test the use of electronic health records and standards-based technology solutions. Ensuring trials assess new drugs in diverse patient populations is also a priority focus for FDA.

The disruptive influence of data transparency in the status quo of product development may have much longer implications to the healthcare process, and information for patients.

With global regulatory changes happening quickly and often, there is concern that sponsors need more robust systems to keep pace and have a global disclosure strategy in place.

Califf tackles the many challenges to finding a balance between clinical trials large enough to assess all relevant populations and small enough to include deep data on each patient.

OND Director John Jenkins would like to see sponsors invest in more “me-better” drugs-as opposed to “me-too” medicines-to expand treatment options for patients and to boost competition among manufacturers.

Jill Wechsler on why the FDA program that encourages biopharma companies to develop new treatments for rare and neglected diseases has been in the spotlight recently.

CDRH announced its top 10 Regulatory Science Priorities for Fiscal Year 2016, and stated that these priorities are more than a mere philosophical statement of topics of interest; rather, these priorities are expected to influence CDRH intramural funding decisions.

These three areas will be at center of drug development discussions in the year ahead.

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

Pharma and biotech companies are working with academics and health care organizations to establish systems for collecting and sharing the results of clinical trials, but they have far to go, according to a recent analysis of industry adherence to data transparency requirements.  A report from the non-profit Bioethics International finds that for a group of new drugs approved by FDA in 2012, large pharma companies fell “below legal and ethical standards” for making public information from the relevant clinical trials.

. 

Tips for avoiding a clinical hold.

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

Approved by the European Parliament in April 2014 is EU Regulation 536/2014, which replaces the decade-old Directive 2001/20/EC – the Clinical Trials Directive. While approved last year, it does not apply earlier than May 28, 2016-leaving interested parties only nine months to prepare for its arrival.

FDA needs to expand and empower its Office of Health & Constituent Affairs (OHCA) and its Patient Liaison Program to better coordinate interactions with individuals and physicians seeking expedited access to experimental therapies

The schedule is particularly tight this time because the user fee reauthorization process coincides directly with the presidential elections.