• Regulatory NewsRegulatory News

    FDA Proposes New Databases to Monitor CAR T-Cell Safety Across INDs

    The US Food and Drug Administration (FDA) wants to create two new databases that will allow it to look at safety and manufacturing information across multiple applications for products within a promising class of cancer immunotherapies called anti-CD19 CAR modified T-cells. FDA officials presented their proposal to pilot the databases last week during a meeting of the Recombinant DNA Advisory Committee (RAC), which is organized by the National Institutes of Health's (NIH...
  • Regulatory NewsRegulatory News

    MDUFA IV: Industry, FDA Iron Out Specifics of $500M Deal

    Industry representatives and the US Food and Drug Administration (FDA) met twice in late January to continue hashing out what will be included in the fourth reauthorization of the Medical Device User Fee Act (MDUFA). In the 27 January meeting, FDA estimated that the additional resources to implement such proposals over the five-year authorization period of MDUFA IV would total $500 million, without inflationary adjustments, and in addition to the base amount of user fees...
  • Regulatory NewsRegulatory News

    First-in-Class, Rare Disease Drug Approvals Dominated in 2015: A Breakdown from FDA

    Last year was a banner year for the US Food and Drug Administration (FDA) in terms of new drug approvals, with many of the new drugs coming to market to help rare disease patients and offer new first-in-class options. The total of 45 approvals was well ahead of FDA’s average of about 28 novel approvals between 2006 and 2014, and 36% of those new approvals were for first-in-class drugs while almost half (47%) were to treat rare diseases, or ailments that impact 200,000 or...
  • Regulatory NewsRegulatory News

    EMA Carries 2014 Momentum, Recommends 39 New Drugs and Sets Orphan Record

    In 2015, the European Medicines Agency (EMA) maintained its momentum from 2014 , granting 93 positive opinions, 39 of which were for new active substances. The agency also recommended 18 orphan drugs for approval, breaking last year's record of 17. Notably, EMA trailed just behind the US Food and Drug Administration (FDA)'s Center for Drug Evaluation and Research (CDER) for the year. In 2015, CDER approved 45 new drugs, 21 of which had been granted orphan drug designati...
  • Regulatory NewsRegulatory News

    Researchers See Compounding, Imports as Fix for Pricey Off-Patent Drugs

    Three Johns Hopkins researchers are calling on the US Food and Drug Administration (FDA) to take action on expensive off-patent drugs by permitting bulk compounding and importation of generic formulations of the drug that are approved in other countries. Typically, when a drug goes off-patent and generic versions become available, the price of the drug goes down significantly. Sometimes, due to limited demand or low returns, the market for a particular generic becomes un...
  • Regulatory NewsRegulatory News

    FDA Seeks Participants for Emerging Pharma Manufacturing Tech Program

    The US Food and Drug Administration (FDA) is looking for companies to participate in a program that will review the latest in cutting-edge pharmaceutical manufacturing technology. For companies submitting an investigational new drug application (IND), original or supplemental new drug application (NDA), abbreviated new drug application (ANDA), or biologic license application (BLA) to the Center for Drug Evaluation and Research (CDER) with the use of such emerging manufac...
  • Regulatory NewsRegulatory News

    Senate Committee Advances Bill Redefining When a Drug is Officially Approved

    A bill that would effectively provide manufacturers with more certainty on the marketing exclusivity of approved drugs needing DEA clearance advanced unanimously through a Senate committee Wednesday. Background In order for a drug to be marketed, it must not only be approved by the US Food and Drug Administration (FDA), but the US Drug Enforcement Agency (DEA) must also schedule the drug to a particular class under the Controlled Substances Act (CSA). Under current law...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: India Prepares to Invest in State Drug Regulators (22 September 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Sets Terms for State Regulatory Investment Plan The Indian Ministry of Health has set the terms under which it will distribute the Rs 850 crore ($129 million) state regulatory investment package. States signing up to the memorandum of understanding (MoU) will only continue to receive funding if they achieve certain predefined goals. Ministry of Health officials ha...
  • Regulatory NewsRegulatory News

    Japan Edges out FDA for Fastest Approvals

    In 2014, Japan's regulator, the Pharmaceuticals and Medical Devices Agency (PMDA) edged out the US Food and Drug Administration (FDA) as the world's fastest regulator, with a median approval time of 306 days for new active substances (NASs). New Drug Approvals in ICH Countries A new report by the Centre for Innovation in Regulatory Science (CIRS), New Drug Approvals in ICH Countries 2005-2014 , examines NAS approvals in the US, EU and Japan. The report finds that FD...
  • RAPS' LatestRAPS' Latest

    RAPS Mid-Atlantic Career Day Draws Nearly 100 to Learn, Network

    Earlier this month, nearly 100 regulatory professionals, career changers, students and others gathered at the Montgomery County (MD) campus of Johns Hopkins University to learn, network and perhaps take the next steps in their regulatory careers. This was the second year for this regional career event. It was organized by RAPS DC/Baltimore Chapter Co-Chairs Nancy Singer (pictured), RAC, FRAPS, JD, president, Compliance Alliance LLC; and Daniela Drago, PhD, assis...
  • Regulatory NewsRegulatory News

    FDA Releases Guidance for Clinical Trial Sponsor-Investigators

    New guidance issued by the US Food and Drug Administration (FDA) instructs clinical trial sponsor-investigators on how to complete an investigational new drug application (IND)—an application used by FDA to approve the start of a new trial. As FDA notes at the outset of the new draft guidance document, Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators , "Sponsor-investigators seeking to do clinical research often do not have the reg...
  • Regulatory NewsRegulatory News

    What's a 'New' Drug in the EU? EMA Explains

    When is a chemical entity considered a new active substance (NAS)? The European Medicines Agency (EMA) answers that question and provides clarification on the type of information required to demonstrate that a substance qualifies for NAS status in a draft reflection paper published Friday. Background Obtaining NAS status is important for drug makers, as products granted NAS status benefit from a full 10 years of protection against generic competition. However, to ensur...