Pharmaceutical regulations vary widely in different countries, though new research published Friday in Nature Reviews Drug Discovery offers comparisons in terms of the regulators’ budgets, staff, new drug approvals and timelines for approvals. Of the regulators in the more established major pharmaceutical markets (the authors from the European Center of Pharmaceutical Medicine and Novo Nordisk point to the US, Europe and Japan as being the regulators in such mark...

With a goal of avoiding unnecessary duplication of studies performed on a previously approved drug, the 505(b)(2) pathway allows for a more streamlined development and approval process, but for new drug applications (NDAs), the pathway has not led to shorter approval times, according to a recent analysis conducted by the Tufts Center for the Study of Drug Development. Background Established under the Hatch-Waxman Amendments of 1984 to the Federal Food, Drug, and Cosme...

Despite wide variations across therapeutic areas, FDA review times for new drugs have steadily declined since 2009, according to a report released Tuesday by the California Life Sciences Association and Boston Consulting Group. Back in 2009, FDA was averaging 21 months for reviewing new molecular and biologic entities, but five years later, that average has been cut by more than half to nine months in 2014. In addition, the number of applicants waiting more than two year...

A new report issued by the consulting group PricewaterhouseCooper (PWC) indicates that the US Food and Drug Administration (FDA) is making sustained improvements to its drug and medical device approval processes, resulting in new products reaching consumers more quickly. PWC's report, The FDA and industry: A recipe for collaborating in the New Health Economy , is a wide-ranging look at FDA's performance and industry's assessment of its interactions with the regulator....

Six of the world's most preeminent regulatory bodies have become increasingly adept at approving new drug products more quickly and consistently, according to a new analysis published by the Centre for Innovation in Regulatory Science (CIRS). Background: Study CIRS' analysis looked at new drug approval decisions made over the past decade by six regulators: The US Food and Drug Administration (FDA) The European Medicines Agency (EMA) Japan's Pharmaceutical and Medica...

A new report published by the Tufts Center for the Study of Drug Development (CSDD) validates longstanding data indicating that drugs intended to treat disorders of Central Nervous System (CNS) take longer to develop and are rejected by US Food and Drug Administration (FDA) regulators at a higher rate than are other drugs. Background Disorders of the central nervous system are as diverse as they are challenging to treat. Some of the most common CNS disorders include dep...

A new analysis by the California Healthcare Institute (CHI) indicates that after years of unprecedentedly high review times, the US Food and Drug Administration is finally beginning to accelerate the pace at which it reviews innovative high-risk medical devices. Background The data, contained in CHI's report, Taking the Pulse of Medical Device Regulation and Innovation , found broad improvement at FDA's Center for Devices and Radiological Health (CDRH), which...

Regulatory intelligence is at the heart of every well-informed regulatory decision, and is integral to maximizing effectiveness and influence for the regulatory professional.  The Regulatory Intelligence Quotient is a regular exploration of regulatory intelligence topics by thought leaders in the field. Want to learn more or suggest future topics? Contact us at asksofie@graematter.com In the last Regulatory IQ article, we talked about average review times for 510(k...

Regulatory intelligence is at the heart of every well-informed regulatory decision, and is integral to maximizing effectiveness and influence for the regulatory professional. The Regulatory Intelligence Quotient is a regular exploration of regulatory intelligence topics by thought leaders in the field. Want to learn more or suggest future topics? Contact us at asksofie@graematter.com .  What if there was a particular month when your submission would be cleared f...

New research published by the Manhattan Institute for Policy Research (MIPR), a right-leaning think tank which focuses in part on pharmaceutical regulation policy, indicates that there are wide gaps in performance among the US Food and Drug Administration's (FDA) review divisions, resulting in a "productivity gap" that has left some patients without ready access to new therapies. Background MIPR's research report, An FDA Report Card: Wide Performance Found Among Agenc...

A new report published jointly by the California Healthcare Institute (CHI) and the Boston Consulting Group (BCG) is claiming the US Food and Drug Administration (FDA) is taking longer to approve pharmaceutical products for some areas of unmet medical need as the result of unclear regulatory standards. The report, " Managing Priorities: Therapeutic Area Variation in FDA Drug Regulation ," is a follow-up to one co-authored by CHI and BCG in 2011. The 2011 report notes FDA...

The Government Accountability Office (GAO), the government agency tasked with reviewing and auditing government programs, has found the US Food and Drug Administration (FDA) to be meeting its performance goals for reviewing applications under the terms of the Prescription Drug User Fee Act (PDUFA) . GAO's report to Congress notes FDA has generally "met performance goals for priority and standard New Drug Applications (NDAs) and Biologic License Applications (BLAs) recei...