Category Archive: FDA

Aug 05 2020

New FDA Gudiances for July 2020 and Upcoming Advisory Committee Meetings

  By Joshua Taylor, PhD, RAC, Director – Regulatory Affairs at CATO SMS    Special Interest Guidances/Information Date Posted Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans – Final Guidance 31 Jul 2020 Multiple Function Device Products: Policy and Considerations – Final Guidance 29 …

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Jun 08 2020

New FDA Gudiances for May 2020 and Upcoming Advisory Committee Meetings

By Zachary Swan, PhD, RAC, Associate Director, Regulatory Affairs at CATO SMS    Special Interest Guidances/Information Date Posted Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised) – Final Guidance 28 May 2020 Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide (Revised): Guidance for Industry – Final Guidance 28 May 2020 …

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Feb 04 2020

New FDA Gudiances for January 2020 and Upcoming Advisory Committee Meetings

By Sheila Plant, PhD, MHS, RAC, Senior Director, Regulatory Strategy, CATO SMS Special Interest Guidances/Information Date Posted Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components; Draft Guidance for Industry: Draft Guidance for Industry – Draft Guidance 30 Jan 2020 Arthroscopy Pump Tubing Sets …

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Dec 20 2019

New FDA guidance on alternate approaches in premarket notification for Class II medical devices

By Alice Li, MD, MSc, RAC (CAN), Regulatory Scientist, Cato Research FDA issued “The Abbreviated 510(k) Program – Guidance for Industry and Food and Drug Administration Staff” on 13 September 2019. The content of this guidance supersedes the content from 1998 guidance “The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket …

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Nov 06 2019

New FDA Guidances for October 2019 and Upcoming Adcom Meetings

By Sheila Plant, PhD, MHS, RAC (US), Director, Regulatory Strategy at Cato Research Special Interest Guidances/Information Date Posted Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 – Draft Guidance 01 November 2019 Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment Guidance for Industry – Draft Guidance 01 November 2019 Electronic …

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Oct 08 2019

New FDA Guidances for September 2019

Special Interest Guidances/Information Date Posted Patient-Focused Drug Development: Methods to Identify What Is Important to Patients – Draft Guidance 30 Sep 2019 Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act – Final Guidance 27 Sep 2019 Clinical Decision Support Software – Draft Guidance 27 Sep 2019 General …

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Jul 23 2019

Complicated Drug Product? FDA Releases New Draft Guidance on Instructions for Use to Help Sponsors Communicate Proper Use to the Patient

By Dieanira Erudaitius, Ph.D, Scientist at Cato Research This month, July 2019, the United States Food and Drug Administration (FDA) released a new draft guidance to meet Prescription Drug User Fee Act (PDUFA) VI performance goals for patient‑oriented labeling. This draft guidance provides recommendations on the content and format development for Instructions for Use (IFU) …

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Jun 14 2019

New FDA Guidance’s For May 2019

Special Interest Guidances/Information Date Posted Formal Dispute Resolution: Sponsor Appeals Above the Division Level Guidance for Industry and Review Staff – Final Guidance 30 May 2019 Section 503A Bulks List Final Rule Questions and Answers; Small Entity Compliance Guide;: Guidance for Industry – Final Guidance 24 May 2019 Development of Therapeutic Protein Biosimilars: Comparative Analytical …

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May 10 2019

New FDA Guidance’s for April 2019

Special Interest Guidances/Information Date Posted Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices: Guidance for Industry and Food and Drug Administration Staff – Final Guidance 26 Apr 2019 Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff – Final …

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Apr 24 2019

New FDA Guidance on Natural History Studies for Rare Diseases

In a recent Ask Cato blog post, I summarized a revised FDA guidance issued in January 2019, Rare Diseases: Common Issues in Drug Development.1 The guidance covers a range of topics, including the use of surrogate biomarkers, nonclinical flexibility, and natural history studies, to assist sponsors in conducting more efficient drug development programs for rare …

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