• Regulatory NewsRegulatory News

    Microbiome-Based Products: FDA Delves Into the Unregulated

    As part of a broader push to advance the regulatory science around microbiome-based products, the US Food and Drug Administration and National Institutes of Health will host a workshop on 17 September. Currently, FDA has not approved any microbiome-based probiotics as a live biotherapeutic product (LBP), which is a biologic other than a vaccine that contains living organisms used to prevent or treat a disease or condition in humans. However, there are dietary supplement...
  • Regulatory NewsRegulatory News

    FDA and NCI Draft Pediatric Molecular Target List

    Thanks to the law reauthorizing the user fee programs, known as the FDA Reauthorization Act (FDARA), FDA’s Oncology Center of Excellence Pediatric Oncology Program recently drafted a list of molecular targets to provide better guidance to industry in planning for initial pediatric study plan submissions. The efforts from FDA, with input from the National Cancer Institute (NCI), are meant to increase the number of written requests for pediatric studies of new drugs dev...
  • Regulatory NewsRegulatory News

    FDA Approves First Generic Versions of EpiPen

    The US Food and Drug Administration on Thursday approved Teva Pharmaceuticals’ first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis) in adults and children weighing more than 33 pounds. The approval comes as the US has grappled with shortages of EpiPens  and following delays. The approval means Teva can market its generic, substitutable epineph...
  • Regulatory NewsRegulatory News

    DOJ, DEA Seek 10% Reduction in Opioid Manufacturing

    The Department of Justice (DOJ) and US Drug Enforcement Administration (DEA) on Thursday announced they are seeking a 10% reduction in manufacturing for the six frequently misused opioids for 2019. The proposal would impact the manufacturing of more commonly prescribed schedule II opioids, including oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine, and fentanyl. DEA said the quota was set in consultation with the US Food and Drug Administration and other dat...
  • Regulatory NewsRegulatory News

    Export Certificates for Devices: FDA Issues Draft Guidance

    The US Food and Drug Administration (FDA) on Thursday released new draft guidance to explain the process by which persons can be denied a Certificate to Foreign Government (CFG) for a device and what to do if one receives a denial. The 7-page draft describes the information that FDA’s Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) will provide to a person whose request for a CFG for a device is denied, and t...
  • Regulatory NewsRegulatory News

    Brexit Impact: EMA Suspends Publication of Clinical Trial Data

    As of 1 August, the European Medicines Agency (EMA) has suspended all new activities related to the publication of clinical data. EMA said it will continue to publish clinical data submitted by the end of July but no new data packages will be processed until further notice. “This is a result of the implementation of the third phase of  EMA's business continuity plan  to prepare for its relocation to the Netherlands,” the agency said. EMA has stopped sending “invit...
  • Regulatory NewsRegulatory News

    Health Canada Proposes ‘Pause the Clock’ Mechanism for Premarket Submissions

    Health Canada recently released for consultation a plan to establish a mechanism that allows for the review clock on premarket submissions to be formally paused. “A pause the clock policy will be implemented in parallel with the new user fees for drugs and medical devices, by April 2019,” Health Canada said. The consultation, which is part of the  user fee proposal , seeks to pause the review clock during a review only when pre-specified conditions (triggers) are met...
  • Regulatory NewsRegulatory News

    Merck, GSK, BIO and Pew Comment on Draft Guidance on LPAD Approval Pathway

    Merck, GlaxoSmithKline, BIO and Pew Charitable Trusts weighed in on recent draft guidance on the establishment of a limited population pathway for antibacterial and antifungal drugs (LPAD pathway). The draft is intended to assist sponsors in the development of certain new antibacterial and antifungal drugs for approval under the LPAD pathway, which was created under the 21st Century Cures Act . FDA says it will accept greater uncertainty and higher risk for products...
  • Regulatory NewsRegulatory News

    CDER Officials Discuss Expanding Use of RWD and RWE

    Thanks to the 21st Century Cures Act , by the end of 2018, the US Food and Drug Administration (FDA) has to create a framework to evaluate the use of real world evidence (RWE) to support the approval of new indications for approved drugs or to satisfy post-approval study requirements.  FDA defines RWE, according to a JAMA viewpoint published Monday, as “the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysi...
  • Regulatory NewsRegulatory News

    CDER Warns Four Manufacturers From India, China and Canada

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Tuesday released four warning letters sent to prescription drug, active pharmaceutical ingredient (API) and over-the-counter (OTC) drug manufacturers in China, India and Canada. Outlined below are the violations and FDA’s comments, with links to the warning letters in the sub-headings. Apotex Research Private Limited Just a day after receiving the first expedited generi...
  • Regulatory NewsRegulatory News

    Form 483s in India and China: Crunching the Numbers

    As China and India manufacture about 80% of all active pharmaceutical ingredients (APIs) for the US market, the US Food and Drug Administration (FDA) has the enormous task of chasing down and regulating more than 1,000 manufacturing sites. Thanks to the Freedom of Information Act ,  Focus  obtained from FDA a list of all 483 Form 483s issued to China- and India- based manufacturers in 2017 – revealing many repeat offenders, many warning letters and many companies that ...
  • Regulatory NewsRegulatory News

    Advisory Committee Meeting to Focus on OPQ Priorities

    The Pharmaceutical Science and Clinical Pharmacology Advisory Committee will meet on 20 September to discuss two topics related to the Office of Pharmaceutical Quality’s (OPQ) priority of promoting better medicine. During the morning session of the meeting, the committee will discuss the modernization of assessing drug applications through a Knowledge-Aided Assessment and Structured Application (KASA) initiative. “FDA will seek input on the potential enhancement of a...