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:6/27/2016)... ... June 27, 2016 , ... "FCPX editors can now reveal their media with ... X," said Christina Austin - CEO of Pixel Film Studios. , ProSlice Color ... users can now reveal the media of their split screens with growing colorful ...
(Date:6/27/2016)... ... 2016 , ... A revolution is underway. Brooklyn-based company, ... for the millions of people who require these medical transport services annually. ... the use of technology. Now, SmartEMS has put forth an industry-changing app that ...
(Date:6/26/2016)... ... 2016 , ... On June 10-11, 2016, A Forever Recovery, a holistic treatment ... Longest Breakfast Table in Battle Creek, MI, where the rehabilitation facility is located. This ... of the world’s leading providers of cereal and other breakfast foods. Its residents often ...
(Date:6/26/2016)... ... ... blind and certified personal trainer is helping to develop a weight loss fitness plan that ... the two major problems leading the fitness industry today:, , All ... They don’t eliminate all the reasons people quit their exercise program , ...
(Date:6/25/2016)... ... 25, 2016 , ... Austin residents seeking Mohs surgery services, can now turn ... to Dr. Russell Peckham for medical and surgical dermatology. , Dr. Dorsey brings specialization ... selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was under the direction ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that it ... (procalcitonin) assay as a dedicated testing solution for people ... Roche is the first IVD company in the U.S ... assessment and management. PCT is a sepsis-specific ... blood can aid clinicians in assessing the risk of ...
(Date:6/23/2016)... Bracket , a leading clinical trial technology ... outcomes platform, Bracket eCOA (SM) 6.0, at the 52 ... 30, 2016 in Philadelphia , Pennsylvania.  A ... product of its kind to fully integrate with RTSM, will ... 6.0 is a flexible platform for electronic clinical outcomes assessments ...
(Date:6/23/2016)... LONDON , June 23, 2016 ... environments  Oticon , industry leaders in ... the launch of Oticon Opn ™, the world,s ... world of possibilities for IoT devices.      ... Opn, Oticon introduces a number of ,world firsts,: ...
Breaking Medicine Technology: