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  • Regulatory NewsRegulatory News

    Trump’s ‘Two Out, One In’ Regulatory Policy May Apply to Some FDA Guidance

    The Office of Management and Budget (OMB) late last week offered guidance to federal agencies, including the US Food and Drug Administration (FDA), trying to figure out how the new “two out, one in” executive order (EO) will impact their issuance of guidance and rulemakings moving forward. The Q&A offers some clarity and boundaries for the EO signed last Monday, noting: “The EO’s requirements for Fiscal Year 2017 apply only to those significant regulatory actions, as d...
  • Regulatory NewsRegulatory News

    Trump Pledges to Gut FDA: Which Regulations Need to Go?

    With an executive order (EO) and comments from President Donald Trump yesterday calling for a massive overhaul of US Food and Drug Administration (FDA) regulations, legal experts and former FDA officials are offering some practical and creative ways the agency could clean house. And before this dive into what FDA might or even could do following the signing of this EO , it is important to remember a constant refrain from all experts Focus spoke with: FDA codifies stat...
  • Trump to Pharma CEOs: 75% to 80% of FDA Regulations Will be Eliminated

    In a sign of what’s to come for the US Food and Drug Administration (FDA), President Donald Trump told pharmaceutical company CEOs Tuesday that his administration will be “cutting regulations at a level no one has ever seen before.” The comments, which came before the meeting with CEOs from industry group PhRMA, Merck, Novartis, Johnson & Johnson, Celgene and others, Trump said in terms of the drug approval process: “We’re also going to be streamlining the process, so t...
  • Regulatory NewsRegulatory News

    ‘Two Out, One In’: Trump Signs Executive Order to Repeal Regulations

    President Donald Trump on Monday signed an executive order (EO) that would require all government agencies to eliminate two regulations for every new regulation instituted. The order , which White House officials characterized as a “one in, two out” plan to benefit small businesses, will likely impact the US Food and Drug Administration (FDA) as it applies to every agency but those related to military or national security-related branches of the federal government or ot...
  • Regulatory NewsRegulatory News

    FDA to Issue More Guidance on 3D Printing

    As manufacturers use 3D printing to create devices matched to a patient’s anatomy and devices with complex internal structures, the US Food and Drug Administration (FDA) is working with universities, researchers and industry to further understand these products and issue more guidance. According to a video ( The 3Rs of 3D printing: FDA’s Role ) from FDA posted Wednesday, Lt. James Coburn, senior research engineer at FDA, says, “We’re a long way off from having a 3D print...
  • Regulatory NewsRegulatory News

    2016 in Review for Drug and Device Regulations: An 11th Hour Reckoning

    Turn back the clock to late October and those first 10 months of 2016 look like a relatively commonplace year for the pharma and medical device industries and their US regulatory counterpart, the US Food and Drug Administration (FDA) (on the EU side, Brexit was already causing headaches for the European Medicines Agency (EMA) as early as June). On the positive side: Agreements on the reauthorizations for each of the user fee bills that will help fund FDA for the next...
  • Regulatory NewsRegulatory News

    FDA Issues Long-Awaited Final Rule on Combo Product Postmarket Safety

    More than the seven years after it was first proposed, the US Food and Drug Administration (FDA) on Monday finalized new postmarket safety reporting requirements for combination products. The final rule, first proposed in 2009 , which is the first time the agency has issued specific recommendations for combo products, is part of FDA’s efforts to ensure more consistent postmarketing safety reporting for these drug/device, biologic/device, biologic/drug or drug/biologic/d...
  • ExplainersExplainers
    Regulatory NewsRegulatory News

    Regulatory Explainer: 21st Century Cures Redux and What it Will Mean for FDA

    Lingering for more than two years, the revamped 21st Century Cures bill, unveiled in late November, has now been approved by the House and Senate and President Barack Obama has said he will sign it. The 996-page bill includes major tweaks to the way in which the US Food and Drug Administration (FDA) regulates drugs, devices and biologics, while providing the agency with $500 million over 10 years to implement provisions that seek to move such products to patients more qu...
  • Regulatory NewsRegulatory News

    Four Pharma Companies Lead in Regulatory, Legal Compliance

    Gilead, Novo Nordisk, Eisai and AbbVie have been singled out as the only companies that were not found by a court or regulator over the past two years to have breached criminal or civil laws or codes of conduct related to corruption or unethical marketing, according to the 2016 edition of the Access to Medicines Index. Background Every two years since 2008, the Access to Medicine Foundation publishes a ranking system analyzing 20 different pharmaceutical companies again...
  • Regulatory NewsRegulatory News

    What the Incoming Trump Administration may Mean for FDA, Biopharma and Device Companies

    As pharmaceutical and biotech company stocks saw a quick rise in share prices yesterday, investors seem to believe the incoming Donald Trump administration and the avoidance of a California ballot measure on drug pricing will have a positive impact on the sector as a whole, at least financially. But while Trump has called for a reduction of federal regulations in general, it remains to be seen how he will deal with the US Food and Drug Administration (FDA). Steven Gros...
  • Regulatory NewsRegulatory News

    FDA Amends Definition of Custom Device

    The US Food and Drug Administration (FDA) on Tuesday released a final rule that amends its regulations on the definition of a custom device so as to include new statutory requirements under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). Under the revised provision, as under the original custom device exemption, a device that meets the qualification of a custom device is exemp...
  • Regulatory NewsRegulatory News

    FDA Warns Brazilian OTC Drug Manufacturer

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Brazil’s Mappel Industria de Embalagens last month for four violations, though the over-the-counter (OTC) drug manufacturer told FDA that it did not realize the products were regulated by FDA. FDA’s inspection of the Sao Paulo-based manufacturing facility from 11 April to 15 April found the company: failed to approve or reject all procedures or specifications impacting the identity,...