• Feature ArticlesFeature Articles

    Risk management, drug shortages and the EU portal for clinical trials

    Feature articles during May focused on risk management and mitigation in dealing with contractors and vendors and included articles on best practices in good vendor management, use of risk management to support outsourcing activities, testing in-house versus outsourcing, and outsourcing in regulatory operations. Also included were in-depth examinations of challenges and opportunities in “bespoke” therapies, a critical appraisal of drug shortages in Germany and an update on...
  • Regulatory NewsRegulatory News

    FDA Redrafts GMP Policies for Outsourcing Facilities

    The US Food and Drug Administration (FDA) issued a revised draft guidance Monday on good manufacturing practices (GMP) for outsourcing facilities to reflect 2014 feedback. The draft guidance aims to clarify provisions that became applicable to outsourcing facilities, following the 2013 enactment of section 503B under the FD&C Act that allowed drug compounders to register as outsourcing facilities with FDA. Outsourcing facilities must be GMP compliant and are subject t...
  • Regulatory NewsRegulatory News

    Compounding: FDA Details Policy Priorities for 2018, Finalizes Guidance

    The US Food and Drug Administration (FDA) on Thursday released its priorities for addressing compounded drugs in 2018 after years of developing policies to improve its oversight. Background In recent years, FDA has worked to update its policies on compounded drugs in response to a 2012 fungal meningitis outbreak linked to the New England Compounding Center that led to at least 60 deaths and new requirements brought on by the Drug Quality and Security Act (DQSA) of 201...
  • Feature ArticlesFeature Articles

    Strategies and Tactics to Successfully Outsource Regulatory Work

    This article highlights key learnings, helpful approaches and recommendations on how to successfully outsource operation-based regulatory work. The author Includes tips on knowing the right work to be outsourced, setting expectations, selecting a supplier, overcoming internal resistance to outsourcing, contracting standards and invoicing. Overview Outsourcing is a strategy and practice for achieving savings, reducing costs, speed or raising quality. If work is outsou...
  • Regulatory NewsRegulatory News

    BIO, Pew Weigh FDA's Revised Draft Guidance on Mixing, Diluting or Repackaging Biologics

    The Biotechnology Innovation Organization (BIO) and the Pew Charitable Trusts are offering their input on the US Food and Drug Administration's (FDA) recently revised draft guidance on mixing, diluting or repackaging biologics. While both organizations say the revised draft guidance is a step in the right direction, BIO says several aspects of the guidance still raise concerns. Background FDA first issued its draft guidance on mixing, diluting or repackaging biological...
  • Regulatory NewsRegulatory News

    GAO Report Highlights Ongoing Challenges in Oversight of Drug Compounders

    A new report by the Government Accountability Office (GAO) finds that while the US Food and Drug Administration (FDA) has taken steps to improve its oversight of drug compounders, challenges at both the state- and FDA-level remain. Background Unlike traditional drugmakers, drug compounders are exempt from certain requirements of the Federal Food, Drug and Cosmetic (FD&C) Act . These exemptions allow compounders operating under section 503A of the act to produce drugs w...
  • Regulatory NewsRegulatory News

    New FDA Guidance Tackles Insanitary Conditions at Compounding Facilities

    The US Food and Drug Administration (FDA) on Wednesday issued new draft guidance intended to help drug compounders address insanitary conditions at their facilities. The safety of compounded drugs has been a high profile issue for FDA since 64 people were killed by a fungal meningitis outbreak tied to the New England Compounding Center , a Massachusetts-based compounder, in 2012. Since then, both Congress and FDA have taken steps to improve the safety of compounded ...
  • Regulatory NewsRegulatory News

    Three FDA Final Rules Slated for Release in May

    Although the final action dates for the three US Food and Drug Administration (FDA) rules are not set in stone, the agency has said it may finalize new regulations this month, which deal with medical device trial data, postmarket safety reporting requirements for combination products and revised regulations (pending for almost 10 years) on what companies must register establishments and list medical products. Device Trial Data The final rule on medical device clinical s...
  • Regulatory NewsRegulatory News

    Regulatory Focus Recap: February 2015

    February was a short month. Did you miss out on reading the Regulatory Focus feature articles ? Here’s a recap. If you're not a member of RAPS , see what you've been missing. February’s editorial theme was outsourcing. Check out all the articles on this topic: CROs: Selecting and Managing Contract Regulatory Development Resources Outsourcing Pharmacovigilance in Small Pharmaceutical Companies: A Perspective Outsourcing: Not My Problem? Pharmaceuti...
  • Regulatory NewsRegulatory News

    FDA Announces all User Fees to be Paid by Pharma, Device Industries in 2015

    The US Food and Drug Administration (FDA) has now released all user fee amounts for the coming 2015 Fiscal Year, including fees for medical devices, pharmaceuticals, generic drugs, biosimilar drugs, drugs compounded at outsourcing facilities, animal drugs and generic animal drugs. The current FY 2014 user fees are also displayed, as are fees from FY 2013, when most programs were overhauled under the Food and Drug Administration Safety and Innovation Act (FDASIA) . Thi...
  • Feature ArticlesFeature Articles

    Getting the Match Right

    • 06 May 2014
    Not so long ago, companies hired consultants exclusively for their specialized expertise, to answer thorny questions or to solve tough problems. The consultants I knew in that era wore dark suits and proffered expert advice in paneled conference rooms in exchange for astronomical bill rates. Today's consulting landscape looks vastly different, with companies engaging consultants on short-term and long-term projects to provide support with a surprising variety of everyday ...
  • Feature ArticlesFeature Articles

    Legal Considerations When Outsourcing: Hold on Loosely, but Don’t Let Go

    In 1981, the US rock band .38 Special sang "Hold on Loosely, But Don't Let Go." This song lyric about love also holds true when considering whether to outsource regulatory responsibilities. Companies can attempt to contractually delegate to third parties, and it might make sense in many cases. However, it is important to recognize that a company regulated by the US Food and Drug Administration (FDA) remains on the hook to comply with the Federal Food, Drug, and Cosmetic...