Navigation Links
FDA Announces Initiative to Bolster Generic Drug Program
Date:10/4/2007

Effort will streamline generic drug approval process; provide more options

for consumers, health professionals

WASHINGTON, Oct. 4 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today outlined a program aimed at increasing the number and variety of generic drug products available to consumers and health care providers. Generic drugs generally cost less than their brand-name counterparts and competition among generics has been a key factor in lowering drug prices. The Generic Initiative for Value and Efficiency, or GIVE, will help the FDA modernize and streamline its generic drug approval process.

The agency approved or tentatively approved a record of 682 generic drug products in fiscal year 2007, over 30 percent more than the previous year.

"To keep pace with the increasing number of generic drug applications, FDA will implement some changes to the generic drug approval process," said Gary Buehler, director of FDA's Office of Generic Drugs. "The GIVE plan outlines ways to maximize the use of our resources so that FDA can review and approve even more high quality generic drugs during the upcoming fiscal year than it did in 2007."

As part of the GIVE efforts, FDA is revising the review order for certain drug applications. For example, first generic products, for which there are no blocking patents or exclusivity protections on the reference listed drug, are identified at the time of submission for expedited review. This will mean that these products, for which there are currently no generic products on the market, may reach the consumer much faster.

FDA now has about 215 full-time staff working on the review of generic drug applications. Under GIVE, FDA will hire and train new generic drug reviewers and focus on enhanced use of electronic programs for handling drug submissions and internal documents. When possible, resources from other FDA departments will be engaged in the effort. As well, FDA will increase its communications with generic drug manufacturers and provide training on proper application submission to the industry in meetings and Webcasts.

Generic drugs undergo a rigorous scientific review to ensure that they are of high quality, safe, and effective. Generic drug manufacturers must demonstrate that a generic drug has the same dosage form, strength, route of administration, and conditions of use as the approved brand-name product. Generic drug manufacturers also must demonstrate bioequivalence, meaning they show that the drug delivers the same amount of its active ingredient in the same amount of time as the brand-name counterpart. Bioequivalence is a critical requirement for concluding that the original and generic drugs will produce the same therapeutic results.

For more information

Comprehensive information, including audio and video, about FDA's Generic Initiative for Value and Efficiency (GIVE) is available at http://www.fda.gov/oc/initiatives/advance/generics.html

Consumer Q and A: FDA's New Generic Drug Program http://www.fda.gov/consumer/updates/genericsqa100407.html

FDA's Office of Generic Drugs http://www.fda.gov/cder/ogd/

Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. PM announces a new health care order for India
2. Ramdoss Announces Introduction of RCH-II
3. Britain Announces Third Transfusion Related Mad Cow Case
4. Gates Foundation Announces $287 Million In Grants Towards AIDS Vaccine
5. Tibet Announces the Dalai Lama’s Tour of South Americ
6. NHS announces further Cost cutting Measures
7. Indian PM Announces Of Setting Up India Study Center At Tashkent
8. PowderMed Announces Needle-Less Flu Vaccine
9. Malaysia Announces Prison term On People Donating HIV-Contaminated Blood
10. Australian Government Announces Survey To Tackle Childhood Obesity
11. New Zealand Announces 10-year Plan For Betterment Of Mental Health Care
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... , ... October 13, 2017 , ... ... the certification process to promote standards of excellence for the field of eating ... for March 22 – 25, 2018 in Orlando, Florida at the Omni Resort ...
(Date:10/13/2017)... SAN LUIS OBISPO, Calif. (PRWEB) , ... October 13, 2017 , ... ... with Alzheimer’s or dementia. However, many long-term care insurance companies have a waiver for ... mean is the 90-day elimination period, when the family pays for care, is often ...
(Date:10/13/2017)... ... October 13, 2017 , ... Talented host, ... lowdown on sciatica in a new episode of "Success Files," which is an ... and innovation and investigates each subject in-depth with passion and integrity. , Sciatica ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent and San Francisco dentists, ... cutting-edge Oventus O2Vent technology. As many as 18 million Americans are estimated to ... breathing. Oral appliances can offer significant relief to about 75 percent of people ...
(Date:10/12/2017)... ... October 12, 2017 , ... Asante, a nationally recognized health ... expanded their existing home health joint venture through an agreement, effective October 1, ... joint venture home health company with Asante, delivering clinically integrated care, for the ...
Breaking Medicine News(10 mins):
(Date:9/19/2017)... LOUISVILLE, Ky. , Sept. 19, 2017   ZirMed ... and predictive analytics, today announced that it has been ranked ... the Black Book™ Rankings 2017 User Survey. ZirMed ... software solution for large hospitals and medical centers over 200 ... in Black Book,s healthcare technology user survey history. ...
(Date:9/13/2017)... Sept. 13, 2017   OrthoAtlanta has been named ... Football Host Committee (AFHC) for the 2018 College Football Playoff ... 2018, at Mercedes-Benz Stadium in Atlanta, Georgia ... AFHC "I,m In" campaign, participating in many activities leading up ... ...
(Date:9/12/2017)...  ValGenesis Inc., the global leader in Enterprise ... announce the appointment of Dr. Ajaz Hussain ... Directors and Chairman of Advisory Board beginning September ... to manage their entire validation lifecycle process electronically ... process. Furthermore, ValGenesis VLMS enables rigorous compliance, helps ...
Breaking Medicine Technology: