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    Senate Committee Advances Health Cost Bill With Changes Impacting FDA

    The Senate Committee on Health, Education, Labor & Pensions (HELP) on Wednesday voted 20-3 to advance a bill aimed at lowering health care costs that includes 54 proposals from a bipartisan group of 65 senators, including more than a dozen that impact the US Food and Drug Administration (FDA). The sections on reducing the price of prescription drugs include various changes to the way FDA operates, including alterations to the citizen petition process, modernizing the Or...
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    FDA Plots Shift Away From CSR Pilot to Forge New Transparency on Drug Approval Process

    The US Food and Drug Administration (FDA) on Wednesday sought comments on a new effort to provide more clarity on the agency’s pharmaceutical application review and decision-making process. FDA highlighted two efforts for which it’s seeking further comment: A fledgling pilot program launched in January 2018 that sought to provide more transparency on sponsors’ clinical study reports (CSRs) but only resulted in the release of one CSR, and a new integrated review template...
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    EC Aide-Memoire Aims to Help Drugmakers Comply With GMP Inspections Related to Falsified Medicines Delegated Regulation

    As part of efforts to help drug manufacturers comply with a 2015 EU delegated regulation protecting against falsified medicines, which came into force in February, the European Commission (EC) has published an aide-memoire for good manufacturing practice (GMP) inspections of manufacturers. The document features nine pages of questions that manufacturers can review to ensure they comply with the delegated regulation ahead of an inspection. The regulation deals with the s...
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    EMA Offers Q&A on Using OOS Batches of Authorized ATMPs

    Late last year, Novartis explained how in certain circumstances, it was providing out-of-specification (OOS) doses of its cell therapy Kymriah (tisagenlecleucel) under a compassionate use program in the US. As the company dealt with manufacturing issues, the OOS product was provided at no cost but was still “expected to maintain the risk/benefit profile observed in clinical trials,” a spokeswoman told FiercePharma. In light of this development, on Tuesday the Europ...
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    House E&C Committee Seeks Answers From FDA on Opioids

    A bipartisan group of six congressmen on the House Energy & Commerce Committee sent a letter Tuesday to Acting FDA Commissioner Ned Sharpless requesting a briefing on the agency’s management of safeguards to restrict certain fentanyl products and regarding FDA’s decision in 2001 to expand the label for Purdue Pharma’s Oxycontin. The letter cites a February JAMA study that found that “thousands of patients receiving TIRFs [transmucosal immediate-release fentanyl medi...
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    FDA Updates List of Off-Patent, Off-Exclusivity Drugs Without Generic Competition

    Since 2017, the US Food and Drug Administration (FDA) has been striving to help generic companies understand which brand name drug products are no longer protected by patents or exclusivities and currently have no generic competitors. The agency, which publishes a list of such ingredients with no generic versions and updates it every six months (in June and December), on Monday offered its latest update, with the removal of 11 ingredients because generic competitors hav...
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    Connecticut AG Releases Unredacted Generic Drug Price Fixing Complaint

    Following a court motion to unseal the unredacted complaint against 20 generic drugmakers, including Teva Pharmaceuticals, Novartis’ Sandoz and Mylan Pharmaceuticals, Connecticut Attorney General William Tong on Monday released the more than 500-page document. A partially redacted version of the complaint, released in May , alleges that the drugmakers worked together to conspire with each other to set prices of more than 100 generic drugs. Specifically, the complain...
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    Australia Preps for Medicine Ingredient Name Changes

    As part of a push to align the names of Australia’s medicinal ingredients with names used internationally, Australia’s Therapeutics Goods Administration (TGA) has been transitioning more than 220 ingredient names as part of a process that will last until 1 May 2020. TGA acknowledged that over the years, some of the ingredient names in Australia have become out of date. And although some of the changes are minor spelling corrections (e.g., Amoxycillin to amoxicillin), ot...
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    FDA Finalizes Guidance on Advertising and Promotional Material Submissions

    The US Food and Drug Administration (FDA) on Friday finalized guidance on the requirements and recommendations for submissions of promotional materials for prescription drugs and biological products, including the specific formats needed. The 37-page guidance, drafted in April 2015, describes the various types of voluntary submissions (e.g., launch and non-launch submissions of draft promotional materials for comments) and required submissions of promotional labeling an...
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    New Study Questions the Need for 12 Years of Market Exclusivity for Biologics

    The lengthy preclinical and clinical development necessary to bring a biologic to market has often been cited as one of the central reasons why biologics deserve 12 years of market exclusivity, or about five years more exclusivity than their small molecule counterparts. But a new study published Tuesday in Nature Biotechnology shows that the development time of a new biologic is generally about the same as the development time of a small molecule drug. The authors ...
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    FDA Releases 20 Years of Data on Medical Device Adverse Event Reports

    The US Food and Drug Administration (FDA) recently ended its Alternative Summary Reporting (ASR) program for medical devices, revoked the related exemptions and on Friday made available on its website all adverse event reports received under ASR exemptions from 1999 to 2019. FDA said it initially indended the ASR program to be for “specific well-known and well-characterized events associated with specific devices,” and that exempted submissions excluded events where the...
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    FDA’s OPDP Sends Third Untitled Letter of 2019

    The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) recently released its third untitled letter of 2019 because of a direct-to-consumer video on Aclaris Therapeutics’ Eskata (hydrogen peroxide) that failed to adequately present the drug’s serious risks. The video, which originally aired on ABC’s The View last September, does not include “prominent, balancing risk information about Eskata,” OPDP said, noting that it is indicated f...