Tag Archive: labeling

Sep 19

New FDA Guidances for August 2013

New guidances out last month include several device related guidances including a beloved (at least by me) Q&A guidance on GLPs in premarket device submissions; a listing of FY 2014 medical device small business user fees; and new information on risk-based monitoring, which is being pushed both by FDA and industry. Select Updates for Non-Clinical …

Continue reading »

May 21

New FDA Guidances for April 2013

There were many new Guidances out in April.  Notably, changes in postmarketing periodic safety reporting are discussed in this guidance.  See CATO’s take on some of the changes in postmarket reporting here. SUPAC: Manufacturing Equipment Addendum  Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4 …

Continue reading »

Apr 11

New FDA Guidances for March 2013

FDA released several interesting new guidances last month, including several regarding communications with the FDA. Types of Communication During the Review of Medical Device Submissions is in accordance with the MDUFA III goals and includes descriptions of acceptance review communications, substantive interactions, interactive review, and missed MDUFA decision communications. Formal Meetings Between the FDA and Biosimilar …

Continue reading »

Mar 06

FDA’s New Guidances for February 2013

Several new guidance documents were released by FDA in February 2013, covering a wide range of subjects. S10 Photosafety Evaluation of Pharmaceuticals Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease Class II Special Controls Guideline: Temporary Mandibular Condyle Reconstruction Plate Immunogenicity Assessment for Therapeutic Protein Products Clinical Study Designs for Surgical Ablation …

Continue reading »

Mar 06

FDA's New Guidances for February 2013

Several new guidance documents were released by FDA in February 2013, covering a wide range of subjects. S10 Photosafety Evaluation of Pharmaceuticals Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease Class II Special Controls Guideline: Temporary Mandibular Condyle Reconstruction Plate Immunogenicity Assessment for Therapeutic Protein Products Clinical Study Designs for Surgical Ablation …

Continue reading »

Feb 04

New FDA Guidances for January 2013

FDA has already released a handful of new guidances to start off the year 2013.  They include: Guidance for Industry and FDA Staff: Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA Humanitarian Use Device (HUD) Designations E3 Structure and Content of Clinical Study Reports – Questions and Answers …

Continue reading »

Aug 15

FDASIA, Part 4: Drug Supply Chain, Drug Shortages, and Other Provisions

On 09 July 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA, otherwise known as PDUFA V) was signed into law.  In a 4-part weekly series, we are covering the major changes in FDASIA as follows: Part 1: The “UFAs”: PDUFA, MDUFA, GDUFA, and BsUFA Part 2: Pediatric Drugs and Devices and Medical …

Continue reading »

Aug 07

FDASIA, Part 3: Generating Antibiotic Incentives Now (GAIN) and Drug Approval and Patient Access Changes

On 09 July 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA, otherwise known as PDUFA V) was signed into law.  In a 4-part weekly series, we are covering the major changes in FDASIA as follows: Part 1: The “UFAs”: PDUFA, MDUFA, GDUFA, and BsUFA Part 2: Pediatric Drugs and Devices and Medical …

Continue reading »

Jul 27

FDASIA, Part 2: Pediatric Drugs and Devices and Medical Device Regulatory Improvements

On 09 July 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA, otherwise known as PDUFA V) was signed into law.  In a 4-part weekly series, we are covering the major changes in FDASIA as follows: Part 1: The “UFAs”: PDUFA, MDUFA, GDUFA, and BsUFA Part 2: Pediatric Drugs and Devices and Medical …

Continue reading »

Sep 08

August 2011 FDA Guidances

Here’s a (very lengthy) list of the guidances released by FDA in August 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson. Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring (Draft) Postmarket Surveillance Under Section 522 of the Federal Food, Drug and Cosmetic Act (Draft) Design Considerations for Pivotal Clinical Investigations for Medical …

Continue reading »

Older posts «