New FDA Guidances for January 2019
By Zachary Swan, Ph.D., RAC (US), Regulatory Scientist at Cato Research FDA draft and final guidances released from CDER, CBER, and CDRH in January are posted. In addition, upcoming advisory committee...
View ArticleClik here to view.
Pharmacogenetics- Tailoring your product to fit the genes
Pharmacogenetics – Tailoring your product to fit the genes By Carron Sher, M.D. Senior Clinical Research Physician John received anti-malarial therapy and developed severe hemolytic anemia. He was...
View ArticleClik here to view.
Revised FDA Guidance on Developing Rare Disease Therapies
by Kristen Biernat, Ph.D., Scientist at Cato Research Rare diseases, defined as conditions affecting fewer than 200,000 people in the United States, pose a significant health care concern.1 There are...
View ArticleClik here to view.
Lets talk about Patient Engagement
Why does everyone talk about “Patient Engagement” in clinical trials? By Shirley Greenfeld Senior Clinical Research Associate As trials are becoming longer and more expensive and many of them fail to...
View Article2019 March FDA Guidances
Special Interest Guidances/Information Date Posted Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling Good Review Practice – Final Guidance 27 Mar 2019...
View ArticleClik here to view.
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...
View ArticleComplicated Drug Product? FDA Releases New Draft Guidance on Instructions for...
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 FDA Releases New Draft Guidance on Instructions for Use to Help Sponsors Communicate Proper Use to the Patient By Dieanira Erudaitius, Ph.D, Scientist at Cato Research This...
View ArticleNew FDA Guidances for June to August 2019
Special Interest Guidances/Information Date Posted Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian...
View ArticleNew 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Guidances/Information Date Posted Patient-Focused Drug Development: Methods to Identify What Is Important to Patients – Draft Guidance 30 Sep 2019 Changes to Existing Medical Software...
View ArticleNew 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...
View Article