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    Generic Drugs: FDA Releases 74 Product-Specific Guidances

    As part of its push to increase generic competition, the US Food and Drug Administration (FDA) on Friday published 74 product-specific guidances, including 22 new and 52 revised guidances.   Four of the new draft guidances and 45 of the revised guidances are for complex drug products, including 16 products for which there are currently no approved abbreviated new drug applications (ANDAs).   Among the new product-specific guidances is help for companies looking to ...
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    CDRH Issues Guidance on Brain-computer Interface Devices

    Brain-computer interface (BCI) devices for patients with paralysis or amputation snagged the first leapfrog guidance from the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) of the year, with new draft nonclinical and clinical recommendations. CDRH released the 42-page draft guidance document on Friday to provide new recommendations on Q-submissions and investigational device exemptions (IDEs) of implanted BCI devices for patien...
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    Recon: AbbVie Adds Parkinson’s Gene Therapy to Voyager Pact; Sanofi Says it Gave Payers $12B in Rebates in 2018

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US AbbVie hands Voyager a mega-billions gene therapy deal, with $310M in near-term cash ( Endpoints ) ( Xconomy ) Drug Middlemen Took $123.5 Million in Hidden Fees, State Claims ( Bloomberg ) Sanofi handed payers nearly $12B in drug rebates last year ( BioPharmaDive ) ( Scrip -$) ( Sanofi ) Sackler Embraced Plan to Conceal OxyContin’s Strength From Doctors, Seale...
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    FDA Defends its Efforts to Ensure Generic Drug Quality

    The US Food and Drug Administration (FDA) on Friday sought to quell a series of media reports raising questions with the agency’s declining inspectional work around the globe and concerns with the agency’s oversight of generic drugs. FDA Commissioner Scott Gottlieb and FDA’s Center for Drug Evaluation and Research Director Janet Woodcock wrote in an extended statement that recent press reports inaccurately raised questions with the quality of the US drug supply and wron...
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    FDA Warns of Increased Risk of Death With Gout Medicine Uloric

    The US Food and Drug Administration (FDA) on Thursday said it has concluded there is an increased risk of death with Takeda’s Uloric (febuxostat) when compared to another gout medicine, allopurinol, and the agency added a boxed warning to Uloric. “This conclusion is based on our in-depth review of results from a safety clinical trial that found an increased risk of heart-related death and death from all causes with Uloric,” FDA said in a safety communication. When Ul...
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    Catalyst Defends $375,000 Price Tag for Previously Free Drug

    In response to questions from Sen. Bernie Sanders (I-VT) on the price tag of a new orphan drug, Catalyst Pharmaceuticals on Thursday explained how much it had to invest in Firdapse (amifampridine) to bring it to market and how the previously experimental version of the drug should not be the standard of care. Firdapse is the first drug approved by FDA to treat Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disorder that affects patients' muscles and nerves....
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    Final FDA Rule to Require Foreign Device GCP Compliance Comes into Effect

    The US Food and Drug Administration (FDA) final rule that requires foreign clinical investigations for medical devices to comply with good clinical practice (GCP) requirements came into effect on Thursday.   The 2018 final rule is intended to provide consistency in the agency’s requirements for the acceptance of data derived from medical device clinical investigations, regardless of the type of marketing submission or application and whether the investigation was conduc...
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    FDA Proposes New Rule for Sunscreen Products

    The US Food and Drug Administration (FDA) proposed a new rule on Thursday to update regulatory requirements for most sunscreen active ingredients currently on the US market. The 264-page proposed rule was decades in the making, with collaborators ranging from agency staff and outside scientific experts to patient advocacy groups. The new regulatory framework it describes is aimed at providing better assurance of the safety, efficacy and preventive qualities of over-the-...
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    EMA Opens Consultation on Guideline for Advanced Therapies in Clinical Trials

    The European Medicines Agency (EMA) on Thursday opened for consultation a new guideline on the structure and data requirements for a clinical trial application for exploratory and confirmatory trials with advanced therapy investigational medicinal products (ATIMPs). The 53-page guideline addresses development, manufacturing and quality control, featuring sections on quality documentation (including parts on the active substance and the investigational medicinal product)...
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    FDA Offers Guidance on Nicotine Replacement Therapies

    The US Food and Drug Administration (FDA) on Thursday issued draft guidance providing recommendations to drugmakers looking to develop nicotine replacement therapy (NRT) products to help patients quit smoking.   The 19-page draft guidance comes after FDA held a public consultation on its approach to evaluating NRT products in November 2017 and a public hearing on the matter in January 2018.   FDA says the draft guidance “takes into consideration the feedback re...
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    Swissmedic Begins Working With EudraGMDP Database

    As part of the mutual recognition agreement between the EU and Switzerland, the Swiss Agency for Therapeutic Products (Swissmedic) has begun entering information on good manufacturing practice (GMP) compliance and manufacturing authorizations into the EU’s EudraGMDP database. The European Medicines Agency (EMA) noted on Thursday that the Swissmedic entries apply to all new or renewed manufacturing authorizations and the related GMP-certificates issued using new template...
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    Recon: Merck Acquires Immune Design for $300M; CMS Projects US Health Spending to Rise 5.5% Annually Over the Next Decade

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US health spending to rise 5.5 percent per year over next decade: CMS ( Reuters ) ( STAT ) Merck’s Roger Perlmutter pays $300M to scoop up a battered Immune Design for its I/O work ( Endpoints ) Bill would let patients buy cheaper insulin from other countries ( The Hill ) Florida governor wants to import drugs from Canada ( AP ) Canadian shelves ‘would run dr...