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    Industry Calls on FDA to Streamline Process of Providing Marketing Status Updates

    Industry groups PhRMA and the Association for Accessible Medicines (AAM), as well as companies Pfizer and Teva Pharmaceuticals are calling on the US Food and Drug Administration (FDA) to tweak and clarify recently drafted guidance on marketing status updates. The draft guidance from January helps sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) understand what information they have to share with FDA on the marketing status of thei...
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    Industry Groups Call on FDA to Dispel Biosimilar Misinformation

    The Association for Accessible Medicines (AAM) and its Biosimilars Council, as well as the pharmacy benefit manager association, the Pharmaceutical Care Management Association (PCMA), are backing a Pfizer petition that calls on the US Food and Drug Administration (FDA) to do more to counteract untruthful or misleading information on biosimilars. The AAM comment, related to Pfizer’s petition , specifically targets the term “non-medical switching” and the concept of inte...
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    Biopharma Firms Seek Clarity on FDA Draft Guidance on CMC Annual Reports

    Industry groups and biopharma companies are seeking additional clarity from the US Food and Drug Administration (FDA) regarding draft guidance released in August on chemistry, manufacturing and controls (CMC) postapproval changes for biologics to be documented in annual reports. The draft guidance notes that under FDA regulations, postapproval changes in the product, production process, quality controls, equipment, facilities or responsible personnel that have a ...
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    Continuous Manufacturing: Pfizer, Vertex, AstraZeneca and Others Weigh FDA Plans

    The US Food and Drug Administration (FDA) has been encouraging the adoption of continuous manufacturing techniques for years, and several companies recently offered the agency some suggestions to refine its work around the developing technology. Background In contrast to batch manufacturing - where bulk materials are processed through multiple steps and subsequent batches must wait until the current batch is finished – continuous manufacturing allows companies to m...
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    Generic Industry Group Sues Maryland Over Price Gouging Law

    The Association for Accessible Medicines (AAM), a trade group representing US manufacturers of generic drugs and biosimilars, on Thursday sued Maryland over a new law that will impose fines on generic drugmakers if prices rise by too much or too quickly. Maryland Gov. Larry Hogan (R) allowed the generic drug price gouging bill,  HB 631 , to become law in June, though he did not sign the bill and expressed reservations about "unintended consequences" as well as "le...
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    Generic Drug Industry Group Seeks FDA Regulation Changes

    The Association of Accessible Medicines (AAM), formerly known as the Generic Pharmaceutical Association, has recommended five major US Food and Drug Administration (FDA) regulation tweaks in a letter to the Department of Commerce. In addition to citing a lack of clarity in the regulations governing the permitting processes of large life sciences projects, David Gaugh, SVP for sciences and regulatory affairs at AAM, called for five actions to reduce the regulatory bu...
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    Failure to Reauthorize User Fee Programs Would Result in About 3,000 FDA Layoffs

    Representatives from the biotechnology, medical device and generic drug industries told members of the Senate Committee on Health, Education, Labor & Pensions on Tuesday that if the five-year user fee programs are not reauthorized, the US Food and Drug Administration (FDA) would likely see more than 3,000 job cuts. Those layoffs, if Congress and President Donald Trump fail to act before 1 August or Congress’ summer recess, would significantly curtail new medical product...
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    Biosimilars Council Urges Supreme Court to Reject Additional Six Months Exclusivity for Biologics

    In an amicus brief filed on Friday, the Biosimilars Council, a division of the newly rebranded Association for Accessible Medicines (previously the Generic Pharmaceutical Association), argues that the US Supreme Court should not give biologic manufacturers an additional six months of market exclusivity beyond the “already-generous twelve years” granted. The 49-page brief comes as the Supreme Court will hear oral arguments on 26 April over a dispute between Novartis’ ...