Search Results for FDA

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House Drafts FY 2018 FDA Budget With Same Appropriation Levels as 2017 By Zachary Brennan - Published 27 June 2017

The House Appropriations Committee on Tuesday released the fiscal year 2018 Agriculture Appropriations bill, which would enact a total of $2.8 billion in discretionary funding for the US Food and Drug Administration.

Categories: News, US, FDA, Due Diligence, Regulatory intelligence, Regulatory strategy

Tags: FDA FY 2018, FDA budget, FDA appropriations

Regulatory Recon: Merck Cholesterol Drug Surprises With Phase III Success; Bain and Cinven's €4.1B Stada Buyout Falls Through (27 June 2017) By Michael Mezher - Published 27 June 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: Gottlieb Prioritizes Release of CRLs; FDA Approves Portola's Blood Clot Prevention Drug (26 June 2017) By Michael Mezher - Published 26 June 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: FDA Rejects Pfizer Epogen Biosimilar Over Warned Manufacturing Site; Novartis, CSL Behring & Roche Pick Up US Approvals (23 June 2017) By Michael Mezher - Published 23 June 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: Novartis Drug Cuts Heart Attack, Stroke Risk in Phase III Trial; Kamada Withdraws EU Application for ALPHA-1 Antitrypsin Drug (22 June 2017) By Michael Mezher - Published 22 June 2017

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Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulating CRISPR: FDA and Industry Offer Perspective By Zachary Brennan - Published 21 June 2017

Although the US market is likely more than a year or two away from seeing any commercialized medical products that rely on CRISPR-Cas9 technology, the rapidly developing field has already grabbed the attention of the US Food and Drug Administration (FDA) and other drug regulators.

Categories: News, Europe, US, EMA, FDA, Biologics and biotechnology, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: CRISPR-Cas9, CRISPR regulation, FDA and CRISPR, Editas, Intellia, CRISPR Therapeutics

Regulatory Recon: Draft Drug Pricing Order Proposes to Ease Regulations; FDA Approves Shire's Long-Acting ADHD Drug (21 June 2017) By Michael Mezher - Published 21 June 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon:  Pamplona to Buy CRO Parexel for $5B; FDA Approves Melinta Antibiotic to Treat Skin Infections (20 June 2017) By Michael Mezher - Published 20 June 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: Seattle Genetics Halts Trials Due to Patient Deaths; Novartis' Rituxan Biosimilar Gets EU Approval (19 June 2017) By Michael Mezher - Published 19 June 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: Adamis Wins FDA Approval for EpiPen Rival; BMS to Sell Ireland API Plant to SK Biotek (16 June 2017) By Michael Mezher - Published 16 June 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: Google, Novartis Back Medicxi's $300M Biotech Fund; China's Rise in Biotech (15 June 2017) By Michael Mezher - Published 15 June 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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FDA Pilot to Sign Off on Low-Risk Digital Health Products Without Premarket Review By Zachary Brennan - Published 15 June 2017

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Thursday announced an upcoming pilot program that would create a third-party certification program under which lower-risk digital health products could be marketed without FDA premarket review and higher-risk products could be marketed with a streamlined FDA review.

Categories: News, US, FDA, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: digital health, FDA digital health, software as a medical device

Regulatory Recon: NICE Rejects Pfizer's Besponsa for ALL; Sanofi to Increase Investment in Biologics Production (14 June 2017) By Michael Mezher - Published 14 June 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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FDA Offers Biomarker Qualification Case Studies By Zachary Brennan - Published 14 June 2017

As part of an educational series on qualifying biomarkers for use in drug development, the US Food and Drug Administration (FDA) has released two fictitious examples of how biomarkers can improve the drug development process and how FDA works with researchers, pharmaceutical companies and patient advocates to qualify biomarkers.

Categories: News, US, CDER, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: biomarker qualification, FDA case studies, biomarkers, drug development

Industry Supports FDA Proposal to Create New Office of Patient Affairs By Zachary Brennan - Published 13 June 2017

Industry groups BIO and TransCelerate, as well as companies GlaxoSmithKline and Shire, have offered their support for the creation of a new office at the US Food and Drug Administration (FDA) focused on patient affairs.

Categories: News, US, FDA, Biologics and biotechnology, Business and Leadership, Drugs, Project management, Regulatory intelligence, Regulatory strategy

Tags: BIO, GSK, TransCelerate, Shire, Office of Patient Affairs, FDA patient engagement

Regulatory Recon: Merck Pauses Two Keytruda Studies After Patient Deaths; Pfizer, Roche & Aspen Face South Africa Pricing Probe (13 June 2017) By Michael Mezher - Published 13 June 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: FDA Rejects Coherus' Neulasta Biosimilar; Chi-Med Seeks CFDA Approval for Cancer Drug (12 June 2017) By Michael Mezher - Published 12 June 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: Japan Scraps Drug Price Cut Proposal; NICE Rejects Zurampic for Hyperuricemia in Gout Patients (9 June 2017) By Michael Mezher - Published 09 June 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: Valeant to Sell Pharma Unit for $930M; South Korea to Fine Novartis Over Drug Promos (8 June 2017) By Zachary Brennan - Published 08 June 2017

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Categories: News, Asia, Europe, US, EC, FDA, Biologics and biotechnology, Drugs, Medical Devices

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Regulatory Recon: Valeant in Talks to Sell Eye-Surgery Assets to Carl Zeiss; Trump Will Keep Collins as NIH Director (7 June 2017) By Michael Mezher - Published 07 June 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: House E&C Committee to Vote on User Fee Reauthorization Wednesday; FDA Approves Valve-in-Valve Use for Edwards' Sapien 3 Valves (6 June 2017) By Michael Mezher - Published 06 June 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: Loxo's Targeted Cancer Drug Sees High Response Rate & More News From ASCO17 (5 June 2017) By Michael Mezher - Published 05 June 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News, ASCO, ASCO17

Regulatory Recon: ViiV, GSK Use Priority Review Voucher for 2-Drug HIV Combo; NICE Backs Opdivo for Classical Hodgkin Lymphoma (2 June 2017) By Michael Mezher - Published 02 June 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: Ohio Sues Five Drugmakers Over Opioid Epidemic; Tesaro Reportedly Exploring Sale (1 June 2017) By Michael Mezher - Published 01 June 2017

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Regulatory Recon: FDA Approves First Strattera Generics; UK’s NICE Backs Keytruda (31 May 2017) By Zachary Brennan - Published 31 May 2017

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Categories: News, Asia, Europe, US, EMA, FDA, Health Canada, NICE, TGA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

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