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  • Regulatory NewsRegulatory News

    Nanomaterials: FDA Issues Draft Guidance for Drugs and Biologics

    The US Food and Drug Administration (FDA) on Friday issued draft guidance detailing a risk-based framework for drugs and biologics containing nanomaterials or made using nanotechnology. According to the agency, nanomaterials can perform a variety of functions in drug products, such as improved targeting of a particular organ or increased bioavailability. FDA says it does not "categorically judge" drugs and biologics containing nanomaterials to be "intrinsically benign o...
  • Regulatory NewsRegulatory News

    FDA Plots New Enforcement Approach for Homeopathic Products

    The US Food and Drug Administration (FDA) on Monday released new draft guidance outlining how it will take a new risk-based enforcement approach to drug products labeled as homeopathic. The agency says it will begin prioritizing enforcement actions against such homeopathic products with reported safety concerns, intended for preventing or treating serious or life-threatening diseases and products aimed at vulnerable populations, among others. However, without new Co...
  • Regulatory NewsRegulatory News

    When Can FDA 'Refuse to File' NDAs and BLAs? New Draft Guidance Explains

    When a new drug application (NDA) or biologics license application (BLA) is deemed incomplete by the US Food and Drug Administration (FDA), the agency can decide not to review the application. So when can this occur? On Tuesday, the agency released draft guidance on what incompleteness means and when it can lead to a "refusal to file" decision. Explained simply: Refuse-to-file actions allow FDA to inform a sponsor as quickly as possible of deficiencies in an NDA or ...
  • Feature ArticlesFeature Articles

    A New Regulatory Paradigm for Medical Devices in India

    This article explains medical device classification rules, manufacturer registration procedures, dossier filing procedures, and pre-clinical and marketing application approval processes. Introduction Medical devices are a multi-billion-dollar global industry with continuous growth opportunities due to advancements in technology and new innovations. However, innovations and new advancements do not always reach patients due to a lack of clarity related to the approval p...
  • Regulatory NewsRegulatory News

    Major vs. Minor ANDA Amendments: Industry Takes Issue With FDA Draft Guidance

    The generic drug industry association, Teva Pharmaceuticals and Sanofi have raised questions in comments released this week on the US Food and Drug Administration’s (FDA) recent draft guidance on abbreviated new drug application (ANDA) amendments. The draft explains when ANDA amendments will be designated as either standard or priority review, classified as either major or minor and receive a goal date based on certain factors, including whether a preapproval ins...
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    More Efficient Rare Pediatric Drug Development: FDA Drafts Guidance

    The US Food and Drug Administration (FDA) on Wednesday released draft guidance that could help speed the development of treatments for rare pediatric disease drugs. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, said the draft guidance "could eliminate the need for certain clinical studies and, when pediatric clinical studies are needed, could reduce the total number of patients who would receive a placebo instead of a potentially helpful...
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    Reproductive Toxicity: FDA Consults on Revised ICH Guideline

    The US Food and Drug Administration (FDA) on Thursday released a draft guidance for consultation on a revision to the International Council for Harmonization (ICH) guideline on reproductive toxicity testing. The draft ICH guideline, S5(R3) Detection of Toxicity to Reproduction for Human Pharmaceuticals , was endorsed by the ICH Assembly in August and is currently in Step 3 of the formal ICH procedure as participating regulators hold public consultations on the guideline...
  • Regulatory NewsRegulatory News

    EMA Drafts Guideline on RSV Treatments and Vaccines

    The European Medicines Agency (EMA) on Tuesday released for consultation a new guideline to help companies develop new medicines, direct-acting antiviral agents, monoclonal antibodies and vaccines to treat and prevent infections caused by the respiratory syncytial virus (RSV). According to EMA, RSV is a common respiratory virus that usually causes mild, cold-like symptoms that most recover from, though RSV can be serious, especially in infants and older adults. Curr...
  • Regulatory NewsRegulatory News

    EMA Consults on Revised Factor VIII Product Guidelines

    The European Medicines Agency (EMA) on Monday issued two draft revised guidelines on plasma-derived and recombinant coagulation factor VIII products that remove requirements for conducting clinical studies in previously untreated patients (PUPs). Background Factor VIII products are used to treat or prevent bleeding in patients with hemophilia A (congenital factor VIII deficiency). The development of inhibitor antibodies is one of the greatest potential complications inv...
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    FDA Issues Disease-Specific Draft Guidance for Pediatric GERD

    The US Food and Drug Administration (FDA) on Thursday issued draft guidance detailing clinical considerations for drugmakers looking to develop products to treat pediatric gastroesophageal reflux disease (GERD). FDA says the draft is meant to be a starting point for discussions between the agency, drugmakers, academia and the public and sets out the agency's current thinking on potential study populations, endpoints and clinical pharmacology issues related to dosing. Sp...
  • Regulatory NewsRegulatory News

    FDA Offers Two Draft Guidances on Drug-Drug Interactions

    The US Food and Drug Administration (FDA) on Wednesday released two draft guidance documents that aim to help drug developers evaluate investigational new drugs for potential drug-drug interactions (DDIs). FDA says the guidances, which will replace 2012 draft guidance entitled “Drug Interaction Studies – Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations,” reflect the agency’s efforts to help drug developers design DDI studies that p...
  • Regulatory NewsRegulatory News

    Sandoz Raises Questions With FDA Draft Guidance on Statistical Approaches for Biosimilars

    Martin Schiestl, chief science officer at Novartis' Sandoz, on Tuesday explained how the US Food and Drug Administration's (FDA) draft guidance on statistical approaches to evaluate analytical similarity poses risks that could end up causing true biosimilars to be rejected randomly. Schiestl told attendees of DIA's biosimilars conference in Bethesda, MD, that the problem is related to equivalence testing, which FDA says in the draft, "is typically recommended for qu...