• Regulatory NewsRegulatory News

    New Formulations Can Delay Generic Drug Entry, Study Finds

    A new study in the Journal of Managed Care & Specialty Pharmacy finds that the introduction of new formulations of drugs often delays the introduction of generic competitors by two or more years.   The study, authored by researchers at Harvard Medical School and Brigham and Women's Hospital's Program on Regulation, Therapeutics and Law (PORTAL), tracked 17 small molecule drugs approved in 2002 over the course of 15 years to see how the introduction of new formulation...
  • Regulatory NewsRegulatory News

    When Can FDA 'Refuse to File' NDAs and BLAs? New Draft Guidance Explains

    When a new drug application (NDA) or biologics license application (BLA) is deemed incomplete by the US Food and Drug Administration (FDA), the agency can decide not to review the application. So when can this occur? On Tuesday, the agency released draft guidance on what incompleteness means and when it can lead to a "refusal to file" decision. Explained simply: Refuse-to-file actions allow FDA to inform a sponsor as quickly as possible of deficiencies in an NDA or ...
  • Regulatory NewsRegulatory News

    ‘FAST’ Generics Act Seeks to Thwart Abuse of FDA Safety Programs

    A bipartisan House bill introduced on Friday seeks to stop pharmaceutical companies from blocking generic competitors by abusing US Food and Drug Administration (FDA) safety programs. The “Fair Access for Safe and Timely Generics Act of 2017,” or “FAST Generics Act of 2017,” introduced by Reps. David McKinley (R-WV) and Peter Welch (D-VT) would amend the Federal Food, Drug, and Cosmetic Act to ensure that eligible generic and biosimilar developers have competitive acce...
  • Regulatory NewsRegulatory News

    FDA Revises Refuse-to-Receive Guidance for ANDAs

    The second revision of the guidance, unveiled Wednesday, is part of the US Food and Drug Administration’s (FDA) attempt to assist abbreviated new drug application (ANDA) sponsors in understanding what deficiencies may cause FDA to refuse to receive (RTR) an ANDA. The guidance features certain recurrent deficiencies that in FDA’s experience have led to an RTR decision, which FDA says means that an ANDA is “not substantially complete.” The guidance also describes how FDA w...
  • Regulatory NewsRegulatory News

    Impurity Deficiencies: How FDA Can Refuse-to-Receive an ANDA

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance that will assist abbreviated new drug application (ANDA) submitters seeking approval of a new strength of a drug. The guidance, for applicants preparing to submit to FDA ANDAs and prior approval supplements to ANDAs, highlights serious deficiencies in impurity information that may cause FDA to refuse-to-receive (RTR) an ANDA. Specifically, FDA says the deficiencies include: “(1) Failing to provi...
  • RAPS' LatestRAPS' Latest

    8 Pieces of Advice for New Regulatory Professionals

    The sheer volume of laws, regulations and guidance documents covering medicines and medical technology means new regulatory professionals have a lot to learn. Even those who have regulatory experience may find themselves behind a steep learning curve when taking on new responsibilities or switching jobs. What should new regulatory professionals or those changing product lines or industries do to position themselves for success? David Chadwick, PhD, RAC, FRAPS, who is ...
  • Regulatory NewsRegulatory News

    FTC Sues Drugmakers for Not Marketing Authorized Generics

    The Federal Trade Commission (FTC) for the first time ever filed a complaint in federal district court this week alleging that an agreement not to market an authorized generic – often called a “no-AG commitment” – is a form of reverse payment and violates antitrust laws. The complaint alleges that Endo Pharmaceuticals and several other drug companies violated antitrust laws by blocking access to generic versions of the pain drug Opana ER (oxymorphone) and the local anest...
  • Regulatory NewsRegulatory News

    Are You a Good Witch, or a Bad Witch?

    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 Upon meeting Dorothy in The Wizard of Oz, Good Witch Glinda asks “Are you a ...
  • Regulatory NewsRegulatory News

    FDA Updates Refuse to Accept Policy for 510(k)s

    This week, the US Food and Drug Administration (FDA) released a new guidance detailing its criteria for accepting 510(k) submissions. The new Refuse to Accept Policy for 510(k)s , which takes effect on 1 October 2015, will take precedence over three previous documents, the 2012 Refuse to Accept Policy for 510(k)s , 510(k) Refuse to Accept Procedures (K94-1) blue book memo and Premarket Notification (510(k)) Refuse to Accept Policy which were released in 2012, 199...
  • Feature ArticlesFeature Articles

    A Lifecycle Approach to ANDA Filings: Lessons Learned

    This article discusses the benefits of implementing a lifecycle approach to ANDA filings to avoid refuse-to-receive notices and deficiencies, ensuring readiness for preapproval inspections. With more than 2,000 Abbreviated New Drug Applications (ANDAs) awaiting review or inspections in 2012, the US Food and Drug Administration (FDA) received additional resources to tackle this backlog with the enactment of the Generic Drug User Fee Amendment (GDUFA ), designed to spee...
  • Regulatory NewsRegulatory News

    Will Your Generic Drug Application Get Rejected by FDA? New Guidance Documents Explain

    The US Food and Drug Administration (FDA) has released two new guidance documents intended to clarify for generic drug makers the criteria by which the agency determines which applications it will "refuse to receive" due to deficiencies in an Abbreviated New Drug Application (ANDA) filing. Background The submission of an ANDA, as with most applications submitted to FDA, involves two stages: the submission of the application to FDA, and FDA agreeing to file the applicati...
  • Regulatory NewsRegulatory News

    Senators Say FDA Import Regulation Would Harm Vulnerable Consumers

    • 10 July 2014
    Four US senators are pressuring the US Food and Drug Administration (FDA) to walk back a rule proposed by the agency in May 2014 that would make it more difficult to import unapproved drugs into the US. Background The proposed rule, Administrative Destruction of Certain Drugs Refused Admission to the United States , is meant to tweak the agency's pharmaceutical import provisions under Section 801(b) of the Federal Food, Drug and Cosmetic Act (FD&C Act) . Under the ...