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  • Feature ArticlesFeature Articles

    Update on trade issues affecting the dietary supplement industry

    This article discusses recent updates on US trade policy issues in the dietary supplement industry. It focuses on the trading relationship between the US and its largest trading partners, including China, and analyzes the ongoing effects of current trade policies on companies that produce, buy, and sell dietary supplements. The authors discuss tools available to US companies to reduce financial liability when trade policies are evolving at a rapid pace.   Introduction ...
  • Regulatory NewsRegulatory News

    ABPI Questions Lack of Details in Latest UK Update on No-Deal Brexit

    The UK’s Secretary of State for Health and Social Care Matt Hancock sent letters Friday on Brexit preparations for medicines supplies, offering details that the pharmaceutical industry group said need to be fleshed out further in the lead up to March 2019. In the event of a no deal scenario, the revised cross-Government planning assumptions show that there will be significantly reduced access across the short straits crossings into Dover and Folkestone for up to six mon...
  • Regulatory NewsRegulatory News

    FTC Settles Complaint Over Deceptive Marketing of Unapproved Cancer Products

    The US Federal Trade Commission (FTC) on Thursday announced it has reached a settlement with CellMark Biopharma related to the company's claims about marketing efforts to sell two of its unapproved products. The settlement comes less than a year after FDA sent CellMark an advisory letter notifying the company that it must remove claims from its website and other materials indicating that CellAssure could treat or prevent cancer. FDA said that the company would need to ...
  • Regulatory NewsRegulatory News

    US Trade Report Highlights Pharma's IP, Counterfeit Issues Abroad

    The Office of the United States Trade Representative's (USTR) 2017 report on the state of intellectual property (IP) protection and enforcement in US trading partners around the world offers a look into concerns regarding market access barriers, particularly for those in the pharmaceutical and medical device industries. The report offers numerous examples of issues pharmaceutical and device companies deal with in some foreign countries, noting that these IP-intensi...
  • Regulatory NewsRegulatory News

    Updated: TTIP on Thin Ice Not Likely to Delay US-EU Mutual GMP Recognition Deal

    A deal to further harmonize and mutually recognize good manufacturing practice (GMP) inspections between the US and EU will not be delayed, as the EU ambassador to the US said Wednesday that the Transatlantic Trade and Investment Partnership (TTIP) is in a state of pause as there is no one within President Donald Trump’s administration with whom to continue discussions. Despite the TTIP pause, a spokesman from the EU ambassador told Focus  via email on Thursday evening ...
  • USTR: 97% of Counterfeit Drugs in US Shipped From Four Countries

    The Office of the US Trade Representative (USTR) is raising new questions in its latest special report about some trade partners’ practices of limiting imports of foreign pharmaceutical and medical devices, as well as major concerns about counterfeit drugs and devices coming from four countries. Trade Issues For the pharmaceutical and device industries, USTR highlights particular issues in Algeria, India, and Indonesia with regards to their “discriminatory, nontranspare...
  • USTR: 97% of Counterfeit Drugs in US Shipped From Four Countries

    The Office of the US Trade Representative (USTR) is raising new questions in its latest special report about some trade partners’ practices of limiting imports of foreign pharmaceutical and medical devices, as well as major concerns about counterfeit drugs and devices coming from four countries. Trade Issues For the pharmaceutical and device industries, USTR highlights particular issues in Algeria, India, and Indonesia with regards to their “discriminatory, nontranspare...
  • Regulatory NewsRegulatory News

    TPP, WTO Deals Reveal Strength of Pharma Industry’s Negotiating Power

    After five years of negotiations, the release of the final text of the long-awaited trade deal, known as the Trans-Pacific Partnership (TPP), on Thursday, as well as concessions made to the US in the WTO’s TRIPS (trade-related aspects of intellectual property rights) deal announced Friday both offer new insight into the strength of the pharmaceutical industry’s lobbying and negotiating powers. TPP Early last month, a number of questions emerged over a sticking point ...
  • Regulatory NewsRegulatory News

    FTC Asks FDA to Reevaluate Framework for Homeopathic Products

    The US Food and Drug Administration (FDA) recently announced it was considering changing the way homeopathic products are regulated and asked for input on whether its current regulatory framework for homeopathic products was sufficient. Now, the Federal Trade Commission (FTC) is weighing in, calling on FDA to "consider amending or repealing its framework for homeopathic medications." Background In March 2015, FDA announced a public hearing to evaluate its regul...
  • Regulatory NewsRegulatory News

    US, Switzerland Campaign to End 20-Year Moratorium on Non-Violation Complaints to WTO

    At the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) meeting last week, the US and Switzerland called on the Council to end a 20-year moratorium on what are called "non-violation complaints," LiveMint reports. While non-violation complaints were rare even before the moratorium, they could provide a way for countries to challenge controversial intellectual property provisions such as Section 3(d) of India's Patents Act . Background Non-v...
  • Regulatory NewsRegulatory News

    Trade Group Wants to See Stricter Limits on Compulsory Licensing

    A US-based trade group wants to see the United States Trade Representative (USTR) pursue stricter limits on the ability of countries to bypass patent protection. In its Special 301 Submission 2015 , the Pharmaceutical Research and Manufacturers of America (PhRMA) argues that compulsory licenses should only be issued in “exceptional situations,” where there is a pressing public health need. What is a Compulsory License? Compulsory licensing (CL) is a legal provisi...
  • Regulatory NewsRegulatory News

    FDA Launches New 'Trusted Trader' Import Program With Long List of Incentives

    The US Customs and Border Protection (CBP) and US Food and Drug Administration (FDA) have announced the launch of a new "Trusted Trader" program meant to expedite the import of products made by companies that meet a rigorous selection process. Background FDA and CBP have long sought to make improvements to the process used to import of products, and particularly pharmaceuticals. As explained in numerous Federal Register announcements over the years, the problem ...