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    CBO Offers Positive Score for Senate Bill to Reform OTC Drug Regulations

    The Congressional Budget Office (CBO) this week said that a Senate bill that would create a new user fee program for over-the-counter (OTC) drugs would not increase the budget deficit. “Over the 2019-2023 period, spending would lag collections by $10 million,” CBO said . Elizabeth Jungman, Pew’s director of public health programs, told Focus : “The CBO score seems like a sign that things are moving in the right direction. Hundreds of millions of Americans use OTC p...
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    Woodcock Lays Out Top CDER Priorities for 2019

    While noting that the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has reached some important milestones in 2018, CDER Director Janet Woodcock also unveiled the center’s priorities for 2019 at the CMS/FDA Summit in Washington, D.C. on Tuesday. “We’ve generally accomplished what we set out to do” in 2018, she said, noting that in the generic drug space, “we’ve reached a steady state,” while in the new molecular entity (NME) space...
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    Biomarker Qualification: FDA Drafts Guidance

    The US Food and Drug Administration (FDA) on Tuesday released draft guidance for industry discussing the recommended components of a biomarker development program, including how to determine the type and level of evidence sufficient to support qualification, and how these components interrelate to inform an evidentiary framework. The draft comes as to date, FDA has qualified eight biomarkers and received 29 submissions . Still, as the draft notes, progress in biomark...
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    FDA Rolls Out Expectations for Biosimilars, Soon-to-Be Biologics

    The US Food and Drug Administration (FDA) on Tuesday released two new draft Q&A guidance documents on biosimilar development and the deemed to be a license provision of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), as well as two final guidance documents on the same topics and one proposed rule amending the definition of a biological product. The efforts are part of FDA’s decade-long work to begin, starting in March 2020, transitioning the approved...
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    Stage Set for Merck’s SCOTUS Case Over Warnings in Labels

    With the acting solicitor general set to participate in oral arguments before the Supreme Court on 7 January, the high court will be deciding a contentious case centered on who has the final say in warning labels on pharmaceuticals. The case, known as Merck v. Albrecht , presents the question of whether Merck should be held liable for failing to warn about the side effects of an osteoporosis drug, despite attempting to change the warning label and having FDA reject its...
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    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...
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    PIC/S Drafts Guidance on Good Practices for Data Management and Integrity

    As data integrity violations continue to be found in Form 483s and warning letters, the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme (PIC/S) released a 52-page draft guidance outlining how an inspector should inspect facilities that must adhere to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards. The guidance, which will be open for consultation until 28 February 2019, was directed by the Australian an...
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    Mini-Exodus From Biosimilar Space Stirs Questions

    In just the past month, three companies have all exited the biosimilar space in one way or another, which has some questioning whether expectations for the biosimilars markets need to be adjusted. The slide began early last month when Sandoz halted its submission for biosimilar rituximab in the US after the Food and Drug Administration (FDA) requested additional information. Stefan Hendriks, global head of biopharmaceuticals at Sandoz, said he believes the needs of...
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    FDA Will Allow Observational Studies to Support Effectiveness Determinations, New Framework Says

    The US Food and Drug Administration (FDA) on Thursday unveiled a new framework discussing how the agency will use real world evidence (RWE) and real-world data (RWD) to help companies win new indications for approved drugs and biologics, expand labels or satisfy post-approval study requirements. As far as what the framework will guide FDA on specifically, the agency said its RWE program will evaluate the potential use of RWE to support changes to labeling about drug pro...
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    IFPMA Seeks Global ban on Gifts and Promotional Aids for Medicines

    As part of a push to align the rest of the world with the US and EU, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) is seeking to establish a global ban on gifts and promotional aids for prescription medicines, wherever its member companies operate. “Any exceptions based on the custom of gifts to mark significant national, cultural or religious events (for example, mooncakes or condolence payments) have also been removed,” the group ...
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    FTC Backs FDA Draft Guidance to Stem the Tide of Abusive Citizen Petitions

    The Federal Trade Commission (FTC) has offered its support for revised US Food and Drug Administration (FDA) draft guidance that will use additional criteria to determine if a citizen petition was submitted to delay the approval of a competing drug. The revised draft offers new considerations for FDA when reviewing citizen petitions, including if a petition was submitted near the expiration of known patent or exclusivity, if a petition was the same or substantially simi...
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    FDA Warns Korean Drug Manufacturer

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 28 November to Korea-based Barox Co., Ltd. for significant violations of current good manufacturing practice (CGMP) regulations. FDA said the firm relabels over-the-counter drug products manufactured by a contract manufacturer and then distributes the drugs to the US. “You have no written documents describing roles and responsibilities of a Quality Control Unit (QCU). All of your empl...