Tag Archive: CDER

Jul 02

New FDA Guidances for June 2015

By Brant Hamel, Ph.D. and Sheila Plant, Ph.D., R.A.C., Regulatory Scientists at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in June 2015, are posted.  In addition, a single upcoming advisory committee meeting to be held in July is also listed below with a link to more information. Special Interest …

Continue reading »

Jan 30

Combination Products: What’s New?

A monoclonal antibody combined with a therapeutic drug. An EpiPen®. A drug packaged with its delivery device. All of these are examples of combination products. A combination product, according to the FDA, is “a product composed of any combination of a drug and a device; a biological product and a device; a drug and a …

Continue reading »

Jan 11

FDA’s Last Guidances for 2012

FDA closed out 2012 by releasing several new guidance documents, including: FDA Oversight of PET Drug Products — Questions and Answers Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs Specifications for Preparing and Submitting Summary Level Clinical Site Data for CDER’s Inspection Planning Providing Submissions in Electronic Format — Summary Level Clinical Site …

Continue reading »

Jan 11

FDA's Last Guidances for 2012

FDA closed out 2012 by releasing several new guidance documents, including: FDA Oversight of PET Drug Products — Questions and Answers Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs Specifications for Preparing and Submitting Summary Level Clinical Site Data for CDER’s Inspection Planning Providing Submissions in Electronic Format — Summary Level Clinical Site …

Continue reading »

Aug 29

Biomarkers: Where are We Today?

The 06 August 2012 announcement by researchers from Boston’s Brigham and Women’s Hospital reporting the identification of a blood biomarker that could lead to earlier diagnoses and perhaps an actual treatment for amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease, was of great interest to me.  First, my brother-in-law, at the peak of his very …

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 »

Oct 25

Pre-IND Submissions in eCTD Format

Historically, we made our Pre-IND submissions in paper (e.g., Pre-IND meeting request, briefing package, and meeting minutes) and we began using eCTD format with the initial IND submission.  However, since FDA assigns a Pre-IND number, which ultimately becomes the IND number, and Module 1 includes at least two places that are appropriate for including Pre-IND …

Continue reading »

Sep 19

FDA Reorganizes Oncology and Hematology Divisions

When we are no longer able to change a situation, we are challenged to change ourselves. Victor Frankl The FDA recently announced that it is reorganizing three divisions (Hematology Products, Drug Oncology Products, and Biologic Oncology Products) from the Office of Oncology Drug Products into a new office: The Office of Hematology and Oncology Products …

Continue reading »

Jul 14

Recap of the DIA Annual Meeting 2011

The 47th Annual DIA Meeting was held on 19-23 June 2011 in Chicago and was a great success with thousands of attendees from the health care industry and regulators from around the world including representatives from the FDA, the EMA, and many other global agencies. This year’s keynote speaker was the renowned AIDS researcher and …

Continue reading »

Mar 14

2010 New Drug Approvals

The U.S. FDA’s Center for Drug Evaluation and Research (CDER) approved 21 new products in 2010 – slightly less than the previous year’s 24 – plus 5 biologics approved by CBER. In light of the FDA’s continued focus on drug safety, I am not surprised that the number isn’t higher. A full list of approvals can be found here.

While the list isn’t long, a few new products stand out to me.

Older posts «