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  • End of the eCTD? FDA Pushes for New KASA System to Improve Assessments

    • 20 September 2018
    The US Food and Drug Administration’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee met Thursday to discuss the positive aspects of adopting a Knowledge-aided Assessment & Structured Application (KASA) platform.
     

  • Clinical Trials: FDA Releases Two Draft Guidances

    • 28 September 2018
    The US Food and Drug Administration (FDA) on Friday unveiled two draft guidances focused on adaptive clinical trial designs and master protocols for cancer treatment trials.
     

  • FDA Reveals Vision for the Transition to ISO 13485

    • 25 September 2018
    An apology was offered to device firms during a session at the MedTech Conference in Philadelphia on Tuesday by the US Food and Drug Administration (FDA) over its recently proposed overhaul of the quality system regulation.

  • Data Integrity a Top Concern for Manufacturers, FDA Says

    • 18 September 2018
    When a pharmaceutical or active pharmaceutical ingredient manufacturer has data integrity issues, that’s likely the tip of the iceberg, Sarah Barkow, of FDA’s Office of Manufacturing Quality, told attendees of the Pharma and Biopharma Outsourcing Association’s annual conference in Rockville, MD.
Regulatory Focus ArticlesRSS 2.0
Recon
Recon: Alnylam Won’t Seek Accelerated Approval for Second RNAi Drug; Roche Expands SQZ Cell Therapy Pact
15 October 2018
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Recon: Abbvie Settles Humira Patent Dispute With Sandoz; BMS’ Opdivo Fails in Ph. III Lung Cancer Study Recon: BMS, Compugen to Test Investigational Antibody and Opdivo in Advanced Solid Tumors Recon: China Approves 17 Cancer Drugs for National Health Insurance Coverage
Regulatory News
New Law to Boost EU-level Cooperation on Health Tech Assessments
15 October 2018
The adopted law on HTAs seeks to minimize duplicate assessments on new medicines and medical devices.
FDA Finalizes Guidance on Targeted Therapies in Rare Genetic Subsets ICER Plots Early Scientific Advice Program for Biopharma Hematologic Malignancies: FDA Offers Draft Guidance on Use of MRD
Feature Articles
Benefit-Risk Management, Global Advertising, Promotion and Labeling Regulations and Regulatory Intelligence
11 October 2018
Feature articles over the past weeks have focused on the ability to assess and manage the benefit-risk profile of drugs, rules for updating prescription drug labels, off-label communications efforts, FDA’s role in regulating the advertising and promotion of prescription drugs, biologics and medical devices, the challenges of regulating mobile applications versus computers systems and recommendations for measuring regulatory compliance of complementary medicines.
Optimize Labeling and Advertising Outcomes through Targeted Subject-Matter Expertise Regulatory Considerations and Best Practices for Promoting an Accelerated Approval Product The Changing Regulatory Landscape of Advertising and Promotion
Explainers
Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers
09 October 2018
Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system.
Regulatory Explainer: Everything You Need to Know About Biosimilars Regulatory Explainer: FDA User Fee Reauthorizations From 2018 to 2022 Regulatory Explainer: 21st Century Cures Redux and What it Will Mean for FDA
About Regulatory Focus

Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products.

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