CDER Ombudsman Releases Annual Report - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

CDER Ombudsman Releases Annual Report


ePT--the Electronic Newsletter of Pharmaceutical Technology

The Center for Drug Evaluation and Research Ombudsman’s office released its annual report detailing the common questions and complaints received by the office in 2011. A total of 461 inquiries was received, an increase of 11% from 2010. The majority of inquiries, 60%, originated from industry, with consumers accounting for 23%, healthcare providers 7%, FDA employees 5%, and other 5%.

The most common questions and complaints received by the office regarded 510(k) submissions, adverse events and safety issues, drug applications, appeals processes, disputes of FDA-483 notices, and problems with the new electronic drug-registration process. Policies and procedures were listed as the number one reason the office was contacted.

The report cites a new trend in an increase in communications from small, emerging biotechnology and pharmaceutical companies, attributing the increase to smaller companies being less familiar with regulatory requirements and smaller companies having a financial need to resolve disputes quickly. Complaints about observations made on FDA-483s continued to be a trend from previous years.

The CDER Ombudsman is an independent public official that works to informally resolve questions, complaints, and comments the office receives from a variety of areas of the pharmaceutical industry, including advocacy groups, research institutions, consumers, healthcare providers, and FDA employees.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here