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:10/13/2017)... ... , ... As health professionals work to improve their approach to healthcare, there ... more than filling out a survey; in many cases health professionals and patients are ... care and research on the importance of active engagement with patients and members of ...
(Date:10/13/2017)... ... October 13, 2017 , ... ... Pharmacy (SOP) alumni Hannah Randall, PharmD ‘17, and Jennifer Huggins, PharmD ’17, ... guideline updates for the primary prevention of cardiovascular diseases during the 15th ...
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network for professional women, ... towards gender equality at their inaugural Summit in New York City in June. The ... social audience of over 3 million. To watch the Mobilize Women video, click ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... “The Journey: ... faced every danger possible to save lost souls in the Philippines. “The Journey: From ... Carole is a dedicated teacher of the Bible. She has taught all ages and ...
(Date:10/12/2017)... ... October 12, 2017 , ... The ... demand of today’s consumer and regulatory authorities worldwide. From Children’s to Adults 50+, ... to meet the highest standard. , These products are also: Gluten Free, ...
Breaking Medicine News(10 mins):
(Date:10/7/2017)... IRVING, Texas , Oct. 6, 2017   ... industry with more than $100 billion in purchasing power, ... industry news and information. The Newsroom is ... chain and industry trends, infographics, expert bios, news releases, ... Besides having access to a wealth of resources at ...
(Date:10/2/2017)... -- Diplomat Pharmacy, Inc. (NYSE: DPLO ) ... , and named its founder as Diplomat,s chief information ... Tennessee , will operate under Diplomat subsidiary Envoy ... for health care partners to include IT outsourcing, consulting, ... "In an interoperable world, technology delivers comprehensive insight and ...
(Date:9/28/2017)... , Sept. 28, 2017 Hill-Rom Holdings, ... 2017 earnings conference call and webcast on Friday, November ... a.m. (EDT) and ending at approximately 8:30 a.m. (CDT) ... discussing the company,s 2017 financial performance and guidance for ... opportunities, initiatives to enhance operational performance, and long-range financial ...
Breaking Medicine Technology: