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  • Regulatory NewsRegulatory News

    FDA's Final Guidance on Generic Drugmaker Correspondence Addresses Some Industry Concerns

    The US Food and Drug Administration's (FDA) final guidance on controlled correspondence between the agency and the generic drug industry released Monday includes some changes that address industry questions and comments. Background Initially released in August 2014, the draft guidance was the fourth guidance document under the 2012 Generic Drug User Fee Act , and was intended to address formal questions posed to FDA prior to the generic drug review process and to clari...
  • Regulatory NewsRegulatory News

    FDA Seeks Industry Representation on 17 of its Drug Advisory Committees

    • 15 April 2015
    The US Food and Drug Administration (FDA) is reaching out to the pharmaceutical and biopharmaceutical industries for input on which industry experts should serve on 18 of its influential advisory committees. Background FDA's advisory committees are comprised of experts—approximately 8-17 of them per committee—which make recommendations to FDA on matters of policy and specific products. For example, a committee might recommend a specific product be approved because of it...
  • BIO, Following PhRMA and EFPIA, Releases Clinical Trial Data Transparency Plan

    The Biotechnology Industry Organization (BIO) has announced that its member companies will soon grant wider access to clinical data, mirroring recent and similar efforts made by the pharmaceutical industry but falling short of calls made by transparency campaigners. Background In recent years, a growing number of voices have been clamoring for greater transparency of clinical trials results, largely after some companies were found to have hidden unfavorable data regardi...
  • IMDRF Asks for Industry Input on Device Harmonization

    Members of the medical device industry will soon get a chance to guide the development of global medical device regulation, if only for a day. Background In a notice sent to members of the device industry on 27 January 2014, the US Food and Drug Administration (FDA) said it and fellow members of the International Medical Device Regulators Forum (IMDRF) will soon be holding a day-long stakeholders meeting. For IMDRF, this isn't a small deal. The group is the successor t...
  • Pharmaceutical Industry Experts Slam FDA's PDUFA Report, Calling it too Vague to be Useful

    The pharmaceutical and biopharmaceutical industries have long been supportive of the user fee schemes used to fund the US Food and Drug Administration (FDA). Originally passed under the Prescription Drug User Fee Act (PDUFA) in 1992 in response to the delay in approvals in drugs in the US compared to in the EU, the basic fee structure-with some added changes and conditions-has been reauthorized another four times, most recently with the passage of the Food and Drug Adm...
  • CDER to Continue Program Giving Regulatory Managers Insight into Pharmaceutical Industry

    US regulators announced this week their intent to continue a program they say allows companies to invite pharmaceutical regulatory officials into their facilities to go on site tours to learn more about the pharmaceutical industry and the way it produces its products. Background: Site Tours Program The plan, known as the Regulatory Project Management Site Tours and Regulatory Interaction Program, or the Site Tours Program, has been in effect in various forms since 1999,...
  • Long-Awaited Sunshine Act Regulation Released

    • 04 February 2013
    The US Centers for Medicare and Medicaid Services (CMS) have released a long-awaited rule that would require all pharmaceutical, medical device and biopharmaceutical companies to report transfers of value to the US government in the hopes of increasing transparency. Background The rules, the Physician Payment Sunshine Act- better known as the Sunshine Act -are a core part of the 2010 Patient Protection and Affordable Care Act . Championed by Sens. Charles Grass...
  • DEA's Regulatory Agenda Affects Pharma Supply Chain, Distribution and Disposal Regulations

    The US Food and Drug's Administration's (FDA) Unified Agenda may have been released late last year, but it's not the only US regulatory agency with the potential to affect the medical device and pharmaceutical industries. Several regulations proposed by the Drug Enforcement Administration (DEA), a division of the US Department of Justice, hold the potential to affect members of industry, and in particular the pharmaceutical industry. One such proposed rule, Disposal of...
  • Trade Group Calls for Mutual Inspection Regime to Safeguard API Supply Chain

    • 13 November 2012
    The European Fine Chemical Group (EFCG) , an industry association of chemical manufacturers-including more than 150 devoted to pharmaceutical manufacturing-is calling for mandatory inspections of all global active pharmaceutical ingredient (API) manufacturing sites through the use of mutual recognition agreements. In a 12 November statement, EFCG said it was, "Proposing a global harmonization of the rules and regulations governing the manufacture of APIs to level the wo...
  • New Rules to Voluntarily Restrict Prescription Drug and Device Marketing in Ireland

    Pharmaceutical and medical devices industries doing business in Ireland may soon find it more difficult to market their products under new guidance developed by the Irish Medical Council aimed at redefining the terms of acceptable conduct between doctors and members of industry. The guidance, a supplement to earlier guidance on the same topic, is specifically aimed at reducing real or perceived conflicts of interest, the majority of which are caused by gifts and othe...
  • Study: Regulatory Noncompliance Plays Big Role in Record-Setting Fines

    Regulatory compliance woes have contributed to record-setting fines paid by pharmaceutical companies since 1991-more than $30 billion in total -- claims a new report published by the health advocacy group Public Citizen. The report, " Pharmaceutical industry Criminal and Civil Penalties: an Update ," follows an earlier 2012 report by the same group in which it found that nearly $20 billion had been recovered by federal officials from pharmaceutical companies since 1991, ...
  • PCORI: Industry Likely Skewing Trial Outcomes to Detriment of Patients, Regulators

    • 26 July 2012
    It's an age-old question: Are life science companies influencing the outcomes of clinical trials? While it may not have a clear-cut answer, a newly-formed semi-governmental agency has announced it's looking to at least partially address it by focusing on how to make clinical trials more responsive to the needs of patients-a development with potentially huge implications for the pharmaceutical and medical device industries. The Patient-Centered Outcomes Research Institute...