Navigation Links
FDA may speed review of new drugs

The Food and Drug Administration has reached agreement with the drug companies it regulates on steps that might speed review of new medications, in return for tens of millions in new industry fees.

The industry has long funded a significant portion of the FDA’s drug review work. But for the first time, the agreement would allow some of that money to go to improved safety monitoring of new drugs// - allowing the FDA to eventually double its number of staffers who oversee the risks of newly sold therapies.

But drug safety advocates say some of the proposal is worrisome. In wake of a dozen drugs pulled off the market because of dangers in recent years, critics say the FDA already is approving drugs too fast and doesn’t adequately monitor problems that can arise when new ones hit the market.

Drug companies have paid millions in user fees that help fund FDA’s review of their products since 1993, under a law called the Prescription Drug User Fee Act, or PDUFA. At the same time, it is costing more to review ever more complex drugs - and companies are discovering fewer of them, meaning the FDA is getting fewer industry payments. The result is a shortfall that reached $30 million this yer.
'"/>




Page: 1

Related medicine news :

1. Emotional callers hamper speedy ambulance dispatch
2. New Drug, Pleconaril speeds recovery from common cold
3. Fireflies help speed development of new drugs
4. Magnetic Resonance Spectrometry for speedy diagnosis of Brain disorders
5. An unlikely contender for speedy surgery recovery: Chewing gum
6. Is There a Connection between Hearing loss and High-speed Dental Tools?
7. Scientists review SARS
8. A Sneak Preview of Human’s Susceptibility to Auto Immune Disease, Allergy, Asthm
9. Thumbs up in weight loss for vegetarian diets: scientific review
10. Cancer drugs in development nearly doubled since 1995
11. Cipla holds talks with mining giant to supply AIDS drugs for South African workers
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:12/11/2016)... ... December 11, 2016 , ... It’s hard for an inventor from ... Tired of the sneezing, watery eyes and general discomfort associated with allergic reactions, he ... then created a prototype of the patent-pending CLEAN AIR NOSE FILTER, an accessory that ...
(Date:12/10/2016)... ... December 10, 2016 , ... ... for Santa are all sources of external stimuli that can put a great ... added pressure to spread holiday cheer through gifts, food and festive gatherings can ...
(Date:12/10/2016)... ... December 10, 2016 , ... When faced with having to use a toilet ... seat to her body, and contamination of children when they use public toilets. This ... problem that many people face. , The patent-pending SANI-POCKET enables a person to use ...
(Date:12/9/2016)... Northern Kentucky - Cincinnati, Ohio (PRWEB) , ... ... ... leader in the production of miniature, folded, pharmaceutical inserts and outserts. As ... & Serialization Device. This addition will enable Flottman to individually code professional ...
(Date:12/9/2016)... ... December 09, 2016 , ... An inventor from Cana, Va., ... ride all types of amusement park rides. , The patent-pending SAFETY STRAP FOR AMPUTEES ... to use and could be set up in a matter of minutes, or even ...
Breaking Medicine News(10 mins):
(Date:12/9/2016)... -- RxWiki Inc., a digital health company that powers the ... of pharmacies through its Digital Pharmacist SaaS platform, today ... on Fire" Award in the Health and Life Sciences ... award as one of Austin,s fastest growing companies," said ... "Our platform gives independent retail pharmacies the digital tools ...
(Date:12/9/2016)... 2016  Forge Therapeutics, Inc. today announced a ... EVT, TecDAX, ISIN: DE0005664809) to advance its novel ... of bacterial infections including those caused by drug ... attractive antibacterial target for more than the past ... starting points has hampered its progress. Forge has ...
(Date:12/8/2016)... YORK , Dec. 8, 2016 ... ... as reducing loss of blood during surgeries, lowering the risks ... and decreasing risks of SSIs. The patient warming systems can ... intravascular warming systems.These benefits in turn reduce the stay at ...
Breaking Medicine Technology: