Cato Research

Author's details

Name: Emily Haga
Date registered: August 15, 2017

Latest posts

  1. New FDA Gudiances for January 2020 and Upcoming Advisory Committee Meetings — February 4, 2020
  2. New FDA Guidances for November and December 2019 and Upcoming Advisory Committee Meetings — January 6, 2020
  3. What’s New Health Canada? November 2019 Updates — December 20, 2019
  4. New FDA guidance on alternate approaches in premarket notification for Class II medical devices — December 20, 2019
  5. New FDA Guidances for October 2019 and Upcoming Adcom Meetings — November 6, 2019

Author's posts listings

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 …

Continue reading »

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 …

Continue reading »

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 …

Continue reading »

Apr 10 2019

2019 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 Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research – Final Guidance 25 Mar 2019 Rare Diseases: Natural History Studies …

Continue reading »

Mar 22 2019

Does the FDA Esketamine Approval Open the Door for Enrichment Trial Designs in Psychiatry?

By Greg Hileman, Ph.D, Senior Director of Regulatory Affairs and Principle Regulatory Scientist at Cato Research   On March 5, the FDA approved Spravato (esketamine) nasal spray, for use in conjunction with an oral antidepressant for treatment-resistant depression. Esketamine is the s-enantiomer of ketamine, approved in the 1970’s as an anesthetic, but used off-label since …

Continue reading »

Mar 20 2019

FDA Approval of New Opioid Drug (DSUVIATM) Stirs Controversy – Is it Necessary or Not?

By Dieanira Erudaitius, Ph.D., Scientist at Cato Research The United States Food and Drug Administration (FDA) granted approval of the opioid analgesic DSUVIATM on 02 November 2018.[[1]] Its intended use is for adults only where acute pain management has no alternative treatment other than an opioid analgesic. DSUVIATM is a sublingual tablet containing sufentanil as …

Continue reading »

Mar 18 2019

New FDA Guidances for February 2019

By Joanne McNelis, Ph.D., RAC (US), Scientist II at Cato Research FDA draft and final guidances released from CDER, CBER, and CDRH in December are posted. In addition, upcoming advisory committee meetings are listed below with links to more information.   Special Interest Guidances/Information Date Posted Evaluation of Bulk Drug Substances Nominated for Use in …

Continue reading »

Mar 12 2019

Lets talk about Patient Engagement

patient engagement , clinical trials

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 meet their recruitment goal, patient engagement plays a key role in the success of a clinical trial. But what is exactly patient engagement and …

Continue reading »

Mar 05 2019

TRAUMATIC BRAIN INJURY

By Mabel Ruscitti and Arnavaz Eduljee, Cato Research AWARENESS: Traumatic Brain Injury (TBI) occurs from a blow, jolt, bump or a penetrating object to the head.[1, 2] Traumatic brain injury can lead to brain cell death, inflammation, edema, hemorrhage, and severe disruption to normal brain cell function.  Concussion injury frequently results in persistent functional impairment …

Continue reading »

Feb 28 2019

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 approximately 7,000 rare diseases that cumulatively affect more than 25 million Americans, half of which are children.2 In addition, most rare diseases are serious …

Continue reading »

Older posts «

» Newer posts