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  • Regulatory NewsRegulatory News

    PhRMA and BIO Offer Glowing Support for PDUFA VI Performance Goals

    More than a year after the pharmaceutical and biotech trade groups began voicing their opinions and crafting the next iteration of the US Food and Drug Administration’s (FDA) Prescription Drug User Fee Act (PDUFA), and both PhRMA and BIO have said they are pleased with the performance goals outlined by and for the agency from 2018 to 2022. Background On 15 July, the US Food and Drug Administration (FDA) released for comment a  46-page document  outlining how the agency ...
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    Pharma Companies Warn of Regulatory ‘Dead Zone’ With FDA’s Interpretation of BPCIA

    Sanofi, Mylan, Novo Nordisk, and industry groups PhRMA and the Biosimilars Council are all calling on the US Food and Drug Administration (FDA) to amend its interpretation of the "deemed to be a license" provision of the  Biologics Price Competition and Innovation Act  (BPCIA) of 2010 as some are saying the current draft guidance could halt biosimilar development for a prolonged period. The provision in the BPCIA in question states that: "An approved application for a ...
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    PhRMA, BIO Double Down on Biosimilar Naming With FDA Petition

    The nontrivial issue of how biosimilars should be named in the US may not go away until the US Food and Drug Administration (FDA) makes a definitive decision on how these new products should be labeled and tracked. On the one hand, these cost-saving biosimilars will need to be clearly distinguished from their reference product so that regulators can track any adverse events and ensure they are safe, though on the other side of the coin, any new labeling requirements coul...
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    Industry Calls for Clarity, Phased Approach for Quality Metrics

    Pharmaceutical industry groups say they support the US Food and Drug Administration's (FDA) plan to request quality metrics from drugmakers, but they also call on the agency to clarify what it wants and implement a phased-in approach. Background In July, FDA released its long-awaited draft guidance , Request for Quality Metrics , which outlined the agency's plans to collect quality metrics to "further develop FDA's risk-based inspection scheduling." While the draft g...
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    Industry Seeks More Specifics on FDA's Flexibility With Orphan Drug Guidance

    Two industry associations and a rare disease patient advocacy group say they want the US Food and Drug Administration (FDA) to clarify its "regulatory flexibility" with orphan drug reviews. Challenges in Orphan Drug Development In August, FDA released a draft guidance intended to address the most common issues faced by drugmakers developing treatments for rare diseases . The guidance notes that FDA's "regulations provide flexibility in applying regulatory standards" a...
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    ICH Makes Organizational Changes

    The International Conference on Harmonisation (ICH) has renamed itself as the International Council for Harmonisation (ICH) and has now become a legal entity under Swiss law. ICH says its changes will help it to expand its membership, which currently includes pharmaceutical regulators from the US, EU, Japan, Canada and Switzerland. "More involvement from regulators around the world is welcomed and expected … This is matched by the possibility of wider inclusion of glob...
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    Final TPP Agreement Draws Ire from Both Sides over Biologics Exclusivity

    Pharmaceutical industry groups and nonprofits expressed disappointment Monday over a compromise in the Trans-Pacific Partnership (TPP) on biologics data exclusivity. The deal, which has previously stumbled over the issue of biologics data exclusivity, would either provide eight years of exclusivity to biologic drugs, or provide five years of exclusivity, plus up to three more years under a regulatory framework for the 12 countries in the trade bloc, which includes the ...
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    Quality Metrics: Industry Reaction to FDA's Draft Guidance

    On Monday, the US Food and Drug Administration (FDA) held a public meeting to discuss its plan to request quality metrics from drug manufacturers. The meeting was the first opportunity for the agency and industry to publicly discuss the plan since FDA released its draft guidance in July . While many questions about the program remain, the agency provided some clarification for industry and said it would not be releasing its final guidance until 2016. The agency is also ...
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    PDUFA VI: FDA Hears Stakeholder Comments in First Public Meeting

    The US Food and Drug Administration (FDA) today heard from various groups representing patients, healthcare professionals and the regulated industry for their input on the iteration of the Prescription Drug User Fee Act (PDUFA). Background In the 1980s, the US lagged behind Europe in drug approvals, and individual drug reviews often took years to complete. These lengthy approval times were a significant source of frustration not only for patients and drug companies, b...
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    Biologics Exclusivity Still Central in Trade Talk Debate

    The length of data exclusivity for biologics remains one of the most controversial aspects of the Trans-Pacific Partnership (TPP), which is poised to be the largest free-trade deal in history. While the US Trade Representative (USTR) and the biopharmaceutical industry have publicly called for a 12-year exclusivity period, Politico reports that some industry lobbyists are tempering their expectations. Background Among the 12 parties to TPP, the United States is the on...
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    Pharmaceutical Trade Groups Propose Overhaul of Drug Safety Update System

    In a rare show of unity, two trade groups respectively representing the branded and generic pharmaceutical industries have proposed an alternate policy meant to replace the US Food and Drug Administration's (FDA) controversial proposal to change the way in which generic drug labels are updated to reflect new safety risks. Background In November 2013, FDA  proposed a rule to allow  generic drug manufacturers to temporarily update their labels if they were made aware of n...
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    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...