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  • Regulatory NewsRegulatory News

    Nonclinical Recommendations for Radiopharmaceuticals: FDA Drafts Guidance

    The US Food and Drug Administration (FDA) on Tuesday released draft guidance on nonclinical study recommendations for microdose radiopharmaceutical diagnostic drugs. The 7-page draft seeks to help developers of these microdose radiopharmaceutical diagnostic drugs on the nonclinical studies recommended to support human clinical trials and marketing authorization. The draft specifically discusses how to refine nonclinical study recommendations for this class of dru...
  • Regulatory NewsRegulatory News

    FDA Releases Dozens of New Bioequivalence Recommendations, Including for Sovaldi

    A new batch of bioequivalence recommendations issued by the US Food and Drug Administration (FDA) aims to make it easier for generic drug manufacturers to eventually make copies of several popular drugs, including Sovaldi (sofosbuvir), Northera (droxidopa), Xtandi (enzalutamide) and Olysio (simeprevir). Background Bioequivalence recommendations are a critical part of the submission of an Abbreviated New Drug Application (ANDA)—the application generic drug companies subm...
  • Regulatory NewsRegulatory News

    How can FDA be Improved? Patient Groups Offer Ideas

    More than a dozen patient groups and trade associations are offering their advice to the US Food and Drug Administration (FDA) on ways the agency can improve its regulatory and administrative processes to take into account the views and expertise of patients and their advocates. Background Since 2012, FDA has launched several initiatives meant to better take into account the views of patients. Some, like its patient-focused drug development initiative , have involv...
  • Regulatory NewsRegulatory News

    FDA-Commissioned Report Makes Major Recommendations on How to Improve CDRH

    US medical device regulators should make several major changes to ensure that they are able to regulate products more quickly, efficiently and predictably, a new report commissioned under the Food and Drug Administration Safety and Innovation Act (FDASIA) says. Background The medical device industry has often lambasted the US Food and Drug Administration's review process as being increasingly  onerous, slow and unpredictable —a view also  shared  by government i...
  • FDA Clears Way for Generics of 26 Popular Drugs

    The US Food and Drug Administration (FDA) has released 26 new bioequivalence (BE) standards intended to facilitate the development of abbreviated new drug applications (ANDAs) that best meet FDA's expectations for evidence. Background Bioequivalence  refers to the "absence of a significant difference" between the bioavailability-specifically the extent and rate of absorption-of two (supposed) pharmaceutical drug equivalents over the course of a period of time, at ...
  • Government Report Details FDA's Progress, Failures in Implementing Improvements

    The Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG)is many things: an investigator of programs, a finder of fraud and a recommender of program improvements. A new OIG report makes the case that another superlative might belong on that list: ignored. The agency puts out dozens of reports each year documenting what it sees as program inefficiencies, problems and weaknesses. In 2012, for instance, the agency has issued reports on the ...
  • FDA Meeting on Hip Implants Recommends Against Use

    A panel of experts convened on Thursday, 28 June by US regulators has recommended against the use of metal-on-metal hip implants in patients, reports the Associated Press. The hips, cleared for use by the US Food and Drug Administration (FDA) through its 510(k) pathway which assesses products for "substantial equivalence" to existing products, have been increasingly under fire in recent months as safety concerns mount. UK regulators recently advised surgeons to stop im...
  • Investigation Clears Faulty Implants of Most Serious Safety Concerns

    The UK's Department of Health (DoH) has released its second and final report on the role of regulatory authorities in the proliferation of defective breast implant products manufactured by the now-shuttered French medical device manufacturer Poly Implant Prothese (PIP). The review, announced in January 2012 by UK Health Secretary Andrew Lansley, was aimed at "ensuring the safety of people seeking cosmetic interventions" after French authorities discovered PIP had sold ...
  • European Ombudsman Chides EMA for Transparency Problems

    A report from the European Ombudsman calls on the European Medicines Agency (EMA) to increase the transparency surrounding its pediatric medicines testing requirements after finding an inconsistent application of regulations and a lack of disclosure from the agency. The inquiry was launched after two pharmaceutical companies-kept anonymous in the complaint, but reportedly Takeda and AstraZeneca -complained they were subject to an unfair application of EMA's 2006 Paediat...
  • New Bill Would Subject Regulations to Quadrennial Legislative Review

    A new bill proposed in the US House of Representatives would require the Office of Information and Regulatory Affairs (OIRA) to compile a report every four years recommending certain regulatory reforms to replace "outmoded, duplicative, ineffective or excessively burdensome" regulations. The bill, the Regulatory Reform Act of 2012 , would also require OIRA to compile a "list of recommendations to consolidate, modify, simplify or repeal" the regulations identified in i...
  • New US Bioeconomy Blueprint Addresses Regulatory Hurdles for Drugs, Medical Devices

    The White House Office of Science and Technology (OST) released its National Bioeconomy Blueprint , which charts the course for the future development of bioscience research in the US and addresses numerous regulatory issues. The blueprint is described as a priority of the administration because of the "tremendous potential for growth and job creation." While basic research is an important aspect of the bioeconomy, said OST, regulatory issues are key drivers of ...