RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

  • Regulatory NewsRegulatory News

    Are the Days of FDA Approving 'Basically Everything' Falling by the Wayside?

    In the not-too-distant past (ie. August), the US Food and Drug Administration (FDA) was vilified by some and praised by others for the steep increase in the number of new molecular entities (NMEs) it was approving, though that supposed leniency may have begun to shift in just the past week. FDA's drug review process has long been recognized as the gold standard globally (FDA even mentioned that gold standard moniker in congressional testimony ) and as recently as 2008, ...
  • Regulatory NewsRegulatory News

    Bill Wants Drugs Approved in Europe to be Available More Quickly to US Patients

    New legislation introduced in the US House of Representatives this week would require the US Food and Drug Administration (FDA) to expedite the review and approval of pharmaceutical products already approved in Europe. Background The bill, the Speeding Access to Already Approved Pharmaceutical Act , is sponsored by Reps. Tim Ryan (D-OH) and Steve Stivers (R-OH), who introduced the same bill in June 2014 . As with the original, the bill targets something known in th...
  • Regulatory NewsRegulatory News

    FDA Touts Strong Drug Approval Performance in 2014

    The US Food and Drug Administration (FDA) is touting the number of new molecular entities it has approved thus far in 2014, saying the numbers are indicative of a "strong year for novel drug approvals." A Strong Year for Approvals "With a few weeks left in December, our Center for Drug Evaluation and Research (CDER) has so far approved 35 novel new drugs in 2014 compared to 27 in 2013," said FDA Commissioner Margaret Hamburg in a posting on the agency's FDA Voice blo...
  • Regulatory NewsRegulatory News

    How Many Drug Companies Manage to Get Two New Drugs Approved by FDA? Not Many

    The development of a new pharmaceutical or biopharmaceutical product is a notoriously difficult process. According to industry data compiled by the Tufts Center for the Study of Drug Development, only about one in 10 drugs entering into Phase I clinical trials will ever be approved by the US Food and Drug Administration (FDA)—and those are just the companies whose drugs actually made it to the clinical development stage.  Getting a drug approved, in other words, can feel ...
  • Regulatory NewsRegulatory News

    How Many Drugs has FDA Approved in its Entire History? New Paper Explains

    Pop quiz: While the US Food and Drug Administration (FDA) approves dozens of drugs each year, how many new drugs—i.e. discounting generic versions of approved drugs—has it approved in its entire existence? Until recently, the answer to that question wasn't easy to find. You couldn't find the answer on FDA's website, and even digging into FDA's so-called "Orange Book," which contains a list of all approved drugs and their generic equivalents, wouldn't give you a complete ...
  • Fitch Report Says NME Approvals Plummet at FDA in Q1, but FDA Data Paint Alternate Picture

    When trying to gauge the success of both the US pharmaceutical sector and the US Food and Drug Administration (FDA), one metric usually reigns supreme: approvals. But despite progress by the latter in shoring up its flagging approval numbers in recent years, a new report indicates the first quarter of 2014 was the worst quarter for approvals in almost 15 years. Background FDA approvals over the last decade have experienced their ups and downs. Consider the following ch...
  • FDA Approvals Strong in 2013, but Far From Highs of 2012

    A new report published by the Center for Drug Evaluation and Research (CDER) shows that while approvals of new molecular entities (NMEs) dipped in 2013 relative to 2012, trends appeared to have held steady compared to the turbulence and uncertainties of the last decade. The report, Novel New Drugs: 2013 Summary , observes that FDA approved 27 new drugs in 2013, down from 39 in 2012 and about even with the 30 approved in 2011. The 2013 total is also higher than th...
  • FDA Argues its NME Approval Record Holds Constant When Adjusted for Quality of Drugs Approved

    Is there an "innovation gap"-that is, a slowdown in the development and approval of truly innovative pharmaceutical products reaching the market-affecting the pharmaceutical industry right now? While the much-discussed theory has more than a few proponents, the US Food and Drug Administration (FDA) isn't one of them, and in a new public missive attempts to pour cold water on something that has "generally been accepted as truth." Background In recent years, FDA has been ...
  • Feature ArticlesFeature Articles

    A Comparative Analysis of Drug Lag in Emerging Markets

    "Drug lag" is the delay in introduction of a new drug into a country. The concept of drug lag was first brought up by William Wardell, a pharmacologist at the University of Rochester School of Medicine. After living in New Zealand and the UK for several years, Wardell realized that several drugs being sold abroad were not available in the US. Wardell published a study  showing that from 1962 to 1971, the UK introduced more new chemical entities (NCEs) and at a faster...
  • FDA's Two-year Approval Record Marks 15-Year Best, Report Finds

    The US Food and Drug Administration (FDA) has approved the same number of drugs during the 2012 fiscal year as it did in 2011, a new FDA report claims-the best two-year approval record in 15 years. The agency's "Fiscal Year 2012 Innovative Drug Approvals" report notes that FDA has already "used expedited approval authorities and flexibility in advising sponsors on clinical trial design to approve 35 new novel drugs" this past fiscal year (1 October 2011 through 30 Sept...
  • Is FDA on Pace to Beat Its 2011 Drug Approval Numbers?

    The US Food and Drug Administration (FDA) is potentially on pace to approve fewer new drug entities than it did in 2011, according to several sources. An analysis by The Street of the remaining 2012 FDA advisory committees-panels of experts who provide non-binding advice to the agency regarding whether to approve a new drug product-shows just 23 more drugs set to go before US regulators before the end of the year. The list includes Pfizer's anti-rheumatoid arthri...
  • Capping Busy Week, FDA Approves Breast Cancer, Multiple Myeloma Drugs

    The US Food and Drug Administration (FDA) approved two new drug entities for treating, respectively, certain forms of breast cancer and multiple myeloma on Friday, 20 July. The approvals capped off a busy week for the agency, marking the fourth approval and second new molecular entity in the five-day period. Afinitor (everolimus) , manufactured by Novartis Pharmaceuticals, was approved for the treatment of postmenopausal women with advanced formone-receptor positive, HE...