• 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 As FDA notes at the outset of the new draft guidance document, Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators , "Sponsor-investigators seeking to do clinical research often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...
  • Feature ArticlesFeature Articles

    China New Drug Applications 2004–14: Regulatory Considerations for Clinical Development Supporting Their Approval

    Local clinical data are essential as supporting evidence for new drug applications (NDAs) in China. This article reviews the clinical development process of 148 new chemical entities (NCEs) and new therapeutic biological products approved in China from 2004 through mid-2014. It provides insights into critical regulatory considerations influencing the number of clinical trial patients and choice of development pathway needed to gain regulatory approval in China. Ch...
  • Regulatory NewsRegulatory News

    Bill Would Give Some Reformulated Drugs Extra Protection from Generics

    New legislation introduced in the US House of Representatives would give some pharmaceutical products an extra two years of marketing exclusivity if their sponsors are able to demonstrate that the redesigned or reformulated drugs improve adherence, decrease abuse or otherwise make the drug safer to take. Background The bill, the Promoting Access for Treatments Ideal in Enhancing New Therapies (PATIENT) Act of 2015 , was introduced in the House on 13 March 2015 by Rep...
  • Regulatory NewsRegulatory News

    House Passes DEA Reform Bill Changing Definition of When a Drug is 'Approved'

    The US House of Representatives has passed a new bill which promises to accelerate market access for new pharmaceutical products requiring review by the US Drug Enforcement Administration (DEA), and also changes the definition of what drug "approval" means for some new drug products. Background The bill in question, the  Improving Regulatory Transparency for New Medical Therapies Act , is meant to address a regulatory process some drug companies have described as a "b...
  • Regulatory NewsRegulatory News

    23 Million Hours Spent Each Year Complying With Clinical Trial Requirements, FDA Estimates

    Conducting clinical research is difficult. Patients need to be protected, protocols adhered to, results meticulously recorded and hundreds of regulations followed. And when all is said and done, the US Food and Drug Administration (FDA) estimates that complying with its clinical trial regulations takes almost 23 million hours each year. Background FDA regulates clinical trials under Chapter 21 of the Code of Federal Regulation , Section 312 (21 CFR 312). The section ...
  • Regulatory NewsRegulatory News

    DEA Scheduling Reform Bill Moves Forward in House

    The House of Representatives’ Energy and Commerce Committee has voted in favor of new legislation that would reform the way in which the US Drug Enforcement Administration (DEA) schedules new drug substances in the hopes of allowing patients to access new therapies more quickly. Background The bill in question, the Improving Regulatory Transparency for New Medical Therapies Act , is meant to address a regulatory process some drug companies have described as a "b...
  • Regulatory NewsRegulatory News

    Generic Drug Industry Gets More Time to Comment on new FDA Regulatory Policies

    The US Food and Drug Administration (FDA) is allowing more time for industry stakeholders and the public to weigh in on whether new regulations or policies are needed to oversee the generic pharmaceutical industry. Background As Focus has previously reported, FDA issued a Federal Register notice in August 2014 announcing that it planned to hold a meeting to discuss the implementation of the Generic Drug User Fee Act (GDUFA) provisions of the Food and Drug Administr...
  • Regulatory NewsRegulatory News

    When is a Drug a 'New' Drug? Legislation Seeks to Change Definition

    New legislation introduced in the US House of Representatives last week seeks to incentivize the development of new combination drugs by redefining what a "new" drug really is. Background Under existing rules administered by the US Food and Drug Administration (FDA), not all new drug products are treated the same. New chemical entities (NCEs) that have never before been approved in the US for any indication are eligible for five years of marketing exclusivity, during wh...
  • Regulatory NewsRegulatory News

    FDA Sees 92% Increase in Requests for Compassionate Access to Medicines in 2014

    Last year, the US Food and Drug Administration (FDA) received—and approved—substantially more requests for "compassionate" access to potentially life-saving treatments than any time since at least 2010, according to new data provided by the regulator. Background The data relate to FDA's "expanded access" program—sometimes called its "compassionate use" program—which was created to allow a pathway for terminally or critically ill patients to obtain access to drugs they...
  • Regulatory NewsRegulatory News

    What's a ‘High Priority’ Drug? Generic Drug Industry Offers Ideas to FDA

    The generic pharmaceutical sector is calling on the US Food and Drug Administration (FDA) to make changes to a proposed policy that would make it easier for regulators to prioritize the review of some new generic drug products for which there is no previously approved generic. Background In August 2014, FDA released a new policy that proposed a major change to the agency's generic drug review policies. Traditionally, FDA has mostly operated on a first-to-file system in ...