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  • Regulatory NewsRegulatory News

    Updated: FDA delays collection of drug manufacturing volume data

    The US Food and Drug Administration (FDA) on Monday announced it will not begin collecting drug manufacturing volume data next month as required by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).   Section 3112 of the CARES Act establishes new reporting requirements for drug manufacturers intended to improve the response to drug shortages, including expanding shortage reporting requirements for life-saving drugs to include drugs that are “critical...
  • Regulatory NewsRegulatory News

    European Commission reviews impact of orphan, pediatric regulations

    The European Commission on Tuesday published the results of a yearslong evaluation of the EU’s orphan and pediatric medicines regulations it says will be used to guide future legislative changes and shape the EU pharmaceutical strategy.   The more than 100-page evaluation reviews the positive impacts and shortcomings of the orphan regulation, Regulation (EC) No 141/2000 , and the pediatric regulation, Regulation (EC) No 1901/2006 , based on external studies and var...
  • Regulatory NewsRegulatory News

    Experts address clinical challenges for ultra-rare diseases at BIO

    A panel of experts at BIO Digital on Wednesday discussed some of the challenges and regulatory considerations for sponsors developing treatments for ultra-rare diseases where clinical trials could involve a very small number of patients.   When asked where companies should begin their development for extremely rare diseases, Brad Glasscock, global vice president and head of global regulatory affairs at BioMarin said, “First and foremost I think is understanding whether...
  • Regulatory NewsRegulatory News

    Orphan drug incentives reviewed at BIO

    Orphan drug designation has been a fruitful pathway for drug development, but unmet need remains. Whether changes are needed to the legislation, and how orphan drug research can incorporate patient-focused drug development principles and make room for modern-day collaboration were topics for expert discussion at an orphan drug-focused session during BIO Digital 2020.   The future looks bright for drug development for rare diseases, said session moderator Natasha Bonhom...
  • 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...
  • Feature ArticlesFeature Articles

    Bespoke therapies – opportunities, challenges, and hope

    This article discusses the advent of bespoke therapies, defined as the tailoring of medical treatment to the individual characteristics or symptoms and responses of a patient during all stages of care and as a new frontier beyond personalized medicine. The author covers the revolutionary genetic tools implementing such therapies and the clinical and nonclinical safety perspectives for bespoke therapies. The author concludes that with bespoke therapies we are entering a new...
  • Feature ArticlesFeature Articles

    Drug shortages in Germany ‒ A critical appraisal

    This article discusses drug shortages in Germany, the root causes of production problems with active pharmaceutical ingredients, and drug product manufacturers. The authors offer analysis from the perspective of a medium-sized generic drug manufacturer. They outline a range of reasons for the shortages, all of which point to a “broken marketplace.” The authors conclude with a discussion of mitigation activities and address the current COVID-19 pandemic. They warn that drug...
  • Regulatory NewsRegulatory News

    Pelosi Drug Pricing Bill Advances on Party-Line Votes

    Two House committees on Thursday advanced on party-line votes Speaker Nancy Pelosi’s (D-CA) bill to allow for the negotiation of certain medicine prices as part of plans to bring down costs in the US. No major amendments were adopted in either the Energy & Commerce or the Education & Labor committees’ meetings, although the amendments in the E&C meeting ranged from carving out specific disease treatments from negotiations to requiring the Health and Human Services Sec...
  • Regulatory NewsRegulatory News

    Another Record Year for Generic Drug Approvals but Questions on Competition Remain

    For each of the last five years, the US Food and Drug Administration (FDA) has set generic drug approval records, but questions have lingered on whether these high approval numbers are translating into competition. FY 2019 figures show a total of 1,171 generic drug approvals (935 full approvals and 236 tentative approvals), which breaks FDA’s previous all-time record of 971 full and tentative approvals for FY 2018 . And although the abbreviated new drug application (...
  • Regulatory NewsRegulatory News

    CBO: Pelosi Bill Will Save Hundreds of Billions, Reduce Number of New Drugs to Market

    The Congressional Budget Office (CBO) late Friday announced that House Speaker Nancy Pelosi’s (D-CA) drug pricing bill would reduce federal direct spending for Medicare by $345 billion from 2023 to 2029, but it would also lead to a reduction of approximately 8 to 15 new drugs coming to market over the next 10 years. The CBO report comes as rhetoric on both sides of the aisle has picked up in recent weeks, with industry group PhRMA referring to the bill, known as HR 3, a...
  • Regulatory NewsRegulatory News

    Is FDA Too Lax With its Drug Approval Standards? Senior FDA Officials Discuss

    From industry to academia, commenters have argued that the US Food and Drug Administration’s (FDA) drug approval standards are becoming inappropriately low and that the required postapproval evaluations are either inadequate or left undone. But three senior FDA officials offered several counterpoints on Monday at the fifth annual Biopharma Congress in Washington, DC. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, explained that the agency ...
  • Regulatory NewsRegulatory News

    Nevada Fines Drugmakers $17M for Failing to Comply With Drug Pricing Law

    The Nevada Department of Health and Human Services this week sent letters to 21 diabetes drug manufacturers seeking $17.4 million in penalties for non-compliance with a new price transparency law. “This legislation requires the Department to compile a report of information related to prescription drugs used to treat diabetes. As part of the legislation, the Department of Health and Human Services (DHHS) can impose a penalty for companies who fail to provide the required...