• Regulatory NewsRegulatory News

    FDA Seeks Comment on WHO Recommendations Restricting Certain Psychotropic Substances

    The Food and Drug Administration (FDA) on Tuesday offered a chance for those interested to submit written comments or request an informal public meeting on recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions on certain drug substances. The comments received will be considered in preparing the US position on these proposals for a meeting of the UN Commission on Narcotic Drugs (CND) in Vienna, Austria,...
  • Feature ArticlesFeature Articles

    IND Application Fast Facts

    This article provides information companies need when filing an Investigational New Drug (IND) a pplication  with the US Food and Drug Administration (FDA) to help make the application process more efficient. It addresses common questions and concerns that develop across multiple companies and multidisciplinary groups. When is there a 30-day FDA review? After filing an IND application with FDA, there is a mandatory 30-day review period. 1 The purpose of this review i...
  • Regulatory NewsRegulatory News

    New FDA Drug Approvals: Breaking Down the Numbers

    If a decline in US Food and Drug Administration (FDA) approvals of new pharmaceuticals is a bad sign for the industry, then 2016 was the worst year since 2010. And with only 18 FDA decisions on new drugs expected in 2017, according to BioPharma Catalyst , the number of FDA approvals may continue to decline to a level the industry has not seen since 2007, when 18 new molecular entities (NMEs) and new biologic license applications (BLAs) were approved. But as John ...
  • Regulatory NewsRegulatory News

    FDA Offers New Bioequivalence Recommendations for 31 Active Ingredients, 13 Revisions

    The US Food and Drug Administration (FDA) on Thursday announced the latest batch of new draft guidance for the generic drug industry with 31 product-specific bioequivalence (BE) recommendations and 13 revisions to prior recommendations. The recommendations, which have been released on an ongoing basis since 2010, provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). The new guidance is for the following activ...
  • Regulatory NewsRegulatory News

    FDA Proposes New Rule on Bulk Substances Used to Compound Drugs

    The US Food and Drug Administration (FDA) on Thursday issued a proposed rule that looks to add six bulk drug substances to a list of such substances that can be used in compounding and to remove four other bulk drug substances that FDA evaluated and should not be included in the list. If the proposed rule is finalized, the six bulk drug substances proposed for inclusion will be the first to be included on what’s known as the 503A bulks list. FDA’s Pharmacy Compoundi...
  • Regulatory NewsRegulatory News

    FDA’s Office of New Drugs Director to Retire

    After nearly 25 years of service at the US Food and Drug Administration (FDA), John Jenkins , M.D., Director of the Office of New Drugs (OND), will retire from the federal government on 6 January 2017. For the past 15 years, Jenkins has led OND in its difficult tasks of setting US standards for new drugs’ safety and efficacy, overseeing the clinical testing of investigational drugs and reviewing marketing applications under Prescription Drug User Fee Act (PDUFA) time...
  • Regulatory NewsRegulatory News

    FDA’s Jenkins on Decline in New Drug Approvals in 2016: Not due to Standards Shift

    With less than half the number of new drugs approved in 2016 ( 19 so far ) when compared to 2015 (45 total ), John Jenkins, director of the US Food and Drug Administration’s (FDA) Office of New Drugs, told attendees Friday at a Prevision Policy conference in Washington, DC, that the decline has not been due to a shift in the agency’s standards or policies. “There are fewer applications in front of us to act upon,” Jenkins said, noting that although he cannot discuss in...
  • Regulatory NewsRegulatory News

    FDA Looks to Decrease Adverse Events With New Home-Use Device Label Database

    As part of efforts to reduce an increasing number of adverse events from home-use medical devices, the US Food and Drug Administration (FDA) is proposing to create an online database of all such device labels and to require companies to submit the labels and package inserts in an electronic format.  The shift comes as FDA reviewers claim that the agency receives reports of approximately three to five of the most serious types of adverse events (deaths, fires, explosions...
  • Regulatory NewsRegulatory News

    A Look Into the Future: FDA Wants to Know What’s Coming for Scientific Advances

    New advances in gene editing, precision medicine and synthetic biology are all likely to have a major impact on how the US Food and Drug Administration (FDA) shapes its regulations in the near- and long-term. Now, FDA is formally asking interested parties to offer some fresh perspectives on these and other emerging technologies and cross-cutting scientific advances that could be of importance to FDA, with a focus on areas that may impact FDA in five to 10 years. “FDA's ...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: TGA Offers Guidance on High-Risk IVD Online Applications (13 September 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Posts Guide to Online Application Form for High-Risk IVDs TGA has released a guide to using its online application form for Class 4 in-house in vitro diagnostic (IVD) devices. In keeping with recent guides created by TGA, the IVD document is a comprehensive walkthrough of the process of applying online for devices that fall into the highest-risk category. Class 4 IV...
  • Regulatory NewsRegulatory News

    Prescription Drug and Biosimilar User Fees to See Major Discounts in 2017

    As an increasing number of new drug applications (NDAs) and biologic license applications (BLAs) are expected to be submitted in 2017, the US Food and Drug Administration (FDA) has lowered some of the application fees by more than $300,000. For 2017, the fee for an NDA requiring clinical data or a biosimilar application requiring clinical data will be $2,038,100, which is $336,100 less than the $2.37 million fee from 2016 . For an NDA not requiring clinical data or a ...
  • Regulatory NewsRegulatory News

    Obama Signs Chemical Safety Bill Into Law

    President Barack Obama on Wednesday signed into law a bill that will overhaul, for the first time in 40 years, the way chemical substances are regulated in the US. Although the new law, which updates the Toxic Substances Control Act of 1976, deals with regulations governed by the Environmental Protection Agency (EPA) rather than the US Food and Drug Administration (FDA), it integrates principles to replace and reduce animal-based tests with human-relevant methods to asse...