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  • Regulatory NewsRegulatory News

    FDA calls for stakeholders to join GDUFA talks

    The US Food and Drug Administration (FDA) this week called on non-industry stakeholders, including advocacy groups, healthcare professionals and other experts, to declare their interest in participating in consultation meetings for the next Generic Drug User Fee Amendments (GDUFA III) program.   The call comes less than two months after the agency held its GDUFA III reauthorization kickoff meeting, during which industry stakeholders sought improvements to the generic...
  • Regulatory NewsRegulatory News

    FDA issues 36 new and revised product-specific guidances

    The US Food and Drug Administration (FDA) on Friday released its latest batch of product-specific guidances, posting 19 new and 17 revised draft guidances, bringing the total number of product-specific guidances issued by the agency to 1,938.   The guidances , which FDA posts quarterly, are intended to promote generic competition by clarifying the agency’s expectations for the studies required to demonstrate that a generic drug is equivalent to a reference listed drug...
  • Regulatory NewsRegulatory News

    FDA explains transfer of ownership policy for generics

    The US Food and Drug Administration (FDA) has issued a new manual of policies and procedures (MAPP) for transferring ownership of drug applications, including those due to corporate mergers and acquisitions.   The new MAPP outlines how Orange Book staff in the Office of Generic Drugs will process requests to transfer ownership of a drug application and explains the responsibilities of the current owner of the drug application as well as the new owner.   To transf...
  • Regulatory NewsRegulatory News

    FDA finalizes recommendations for enrolling males in breast cancer trials

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance making recommendations to sponsors encouraging them to enroll male patients in breast cancer clinical trials.   The final guidance comes one year after the agency issued the draft version for comment and includes only minor changes from the previous iteration. (RELATED: FDA calls for men to be enrolled in breast cancer trials , 26 August 2019) .   As in the draft version, FDA explains that ...
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    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

    LPAD pathway: FDA finalizes guidance

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance explaining its recently created program intended to spur the development of new antibiotic and antifungal drugs intended for limited patient populations.   The final guidance comes more than two years after FDA issued the draft guidance for comment and a year after the agency held a public meeting to receive input on the guidance from the scientific community. (RELATED: FDA details limited ...
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    Global regulators agree on endpoints for COVID-19 therapeutics

    Regulators participating in the International Coalition of Medicines Regulatory Authorities (ICMRA) last week reached a consensus on endpoints that would be acceptable as primary endpoints in randomized controlled trials for therapeutics to treat coronavirus disease (COVID-19).   In a teleconference on 20 July 2020 co-chaired by the European Medicines Agency (EMA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), ICMRA members reviewed potential endpoint...
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    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...
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    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...
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    EC offers antitrust reassurances to generic drugmakers cooperating on shortages

    The European Commission on Wednesday reassured the generic drug association Medicines for Europe that member and nonmember companies can work together to battle shortages of critical hospital drugs to treat COVID-19 patients. The commission explains how generic firms may need to coordinate on stock management and distribution “so that not all undertakings focus on one or a few medicines, while others remain in under-production. Such coordination would be contrary to ant...
  • Feature ArticlesFeature Articles

    OTC monograph reform is now law: What’s next?

    This article discusses the impact of over-the-counter (OTC) monograph reform, part of the recently passed Coronavirus Aid, Relief and Economic Security (CARES) Act . Regulators and public health stakeholders have been championing OTC monograph reform for more than five years. Then, in what seems like a blink of any eye, it is now law, passed by Congress and signed by the President on 27 March 2020 as part of the CARES Act for pandemic relief. The new law reflects the...
  • Regulatory NewsRegulatory News

    FDA seeks withdrawal of heartburn drugs due to new carcinogen concerns

    The US Food and Drug Administration (FDA) on Wednesday requested that all manufacturers of drugs containing ranitidine (commonly known as Zantac and used for heartburn) remove all prescription and over-the-counter (OTC) versions from the market because the carcinogen N-Nitrosodimethylamine (NDMA) has now been found to increase significantly in samples stored at higher temperatures. The announcement is the most serious in a chain of FDA safety advisories related to NDMA ...