FDA review fee increases by 6%
Release time: 2011-09-13 & nbsp & nbsp & nbsp Source:
Business Club, September 13th News A few days ago，Pfizer、Lilly and other pharmaceutical companies reached an agreement with the US regulatory authorities，It is intended to increase the drug review fee by 6%，This is part of the work content approved by the drug review procedures before the 2017 fiscal year in the United States。
stake sports betting appstake online sports bettingIncreasing 40.4 million in 2012
13207_13261，This law allows FDA to fund some projects，These projects have helped developers on how to develop some of the most innovative and most important drugs in recent decades to obtain FDA early suggestions。U.S. Congress must approve this agreement before the law expires on September 30, 2012。
FDA spokesman said，It is expected that the review fee from the pharmaceutical industry will increase by 40.4 million US dollars in 2012，The total revenue of 2013 reached US $ 712.8 billion。FDA after obtaining fees，During the review of the drug, communicate with pharmaceutical companies on the development of new drugs，and ensure that timely review。
Davidwheadon, a senior vice president of the American Drug Research and Manufacturers Association (PHRMA) responsible for science and regulatory affairs, welcomes this，This agreement allows consumers to obtain safe and effective new drugs in time。
According to the data provided by the FDA，In FDA's review fee，The funds provided by the pharmaceutical company account for about 60%。The agreement reached this time includes the My stake betting appStake Sports BettingFDA using additional review time，Make more communication; extend the time limit for the evaluation of the pharmaceutical company after submitting the application from 6 months to 8 months，Extended from 10 months to 12 months。
Carry out third -party review
According to the draft agreement，FDA and the industry reached opinions，The consultant group of the FDA summoned the application of the pharmaceutical company's application for 12 days，Both parties must meet，To allow the pharmaceutical company to have enough time to collect the required data。
The protocol also includes whether the FDA has achieved the drug review target to carry out a third -party review。
Standardize the requirements of risk management through FDA for some drugs，and using a network drug safety tracking system，Evaluate the risk after the drug is listed，Drug safety will be strengthened。
Re -approve the last time the Prescription Pharmaceutical User Payment Law was in 2007，At that time, the US Congress gave the FDA new responsibility，To promote the safety of drugs，It includes requiring to implement risk management stake betting appStake Sports Bettingof some drugs，This moves the FDA to slow down the review process。
Jimgreenwood, chairman of a lobbying group of American Biopharmaceutical Company, said，This protocol will revive the FDA review performance。
Since July 2010，Pfizer and Lili Lili and other companies have been discussing the continuation of the "Prescription Pharmaceutical User Payment Law" with the FDA。Medical Device Manufacturer (such as Johnson & Johnson) pays the product review fee from the FDA，A separate talks with the FDA。
According to the Minutes of the Meeting，The medical device industry has rejected the suggestion made by the FDA，That is, more than double the review fee in the next 5 years，increased from US $ 295 million to $ 770 million。Chairman of the US Advanced Medical Technology Association (Advamed) said，Medical device manufacturers resolutely oppose the unrealistic requirements put forward by the regulatory authorities。Industry thinks，This will postpone the time of product approval。(Author: Wang Di)
stake sports betting appstake online sports bettingIncreasing 40.4 million in 2012
13207_13261，This law allows FDA to fund some projects，These projects have helped developers on how to develop some of the most innovative and most important drugs in recent decades to obtain FDA early suggestions。U.S. Congress must approve this agreement before the law expires on September 30, 2012。
FDA spokesman said，It is expected that the review fee from the pharmaceutical industry will increase by 40.4 million US dollars in 2012，The total revenue of 2013 reached US $ 712.8 billion。FDA after obtaining fees，During the review of the drug, communicate with pharmaceutical companies on the development of new drugs，and ensure that timely review。
Davidwheadon, a senior vice president of the American Drug Research and Manufacturers Association (PHRMA) responsible for science and regulatory affairs, welcomes this，This agreement allows consumers to obtain safe and effective new drugs in time。
According to the data provided by the FDA，In FDA's review fee，The funds provided by the pharmaceutical company account for about 60%。The agreement reached this time includes the My stake betting appStake Sports BettingFDA using additional review time，Make more communication; extend the time limit for the evaluation of the pharmaceutical company after submitting the application from 6 months to 8 months，Extended from 10 months to 12 months。
Carry out third -party review
According to the draft agreement，FDA and the industry reached opinions，The consultant group of the FDA summoned the application of the pharmaceutical company's application for 12 days，Both parties must meet，To allow the pharmaceutical company to have enough time to collect the required data。
The protocol also includes whether the FDA has achieved the drug review target to carry out a third -party review。
Standardize the requirements of risk management through FDA for some drugs，and using a network drug safety tracking system，Evaluate the risk after the drug is listed，Drug safety will be strengthened。
Re -approve the last time the Prescription Pharmaceutical User Payment Law was in 2007，At that time, the US Congress gave the FDA new responsibility，To promote the safety of drugs，It includes requiring to implement risk management stake betting appStake Sports Bettingof some drugs，This moves the FDA to slow down the review process。
Jimgreenwood, chairman of a lobbying group of American Biopharmaceutical Company, said，This protocol will revive the FDA review performance。
Since July 2010，Pfizer and Lili Lili and other companies have been discussing the continuation of the "Prescription Pharmaceutical User Payment Law" with the FDA。Medical Device Manufacturer (such as Johnson & Johnson) pays the product review fee from the FDA，A separate talks with the FDA。
According to the Minutes of the Meeting，The medical device industry has rejected the suggestion made by the FDA，That is, more than double the review fee in the next 5 years，increased from US $ 295 million to $ 770 million。Chairman of the US Advanced Medical Technology Association (Advamed) said，Medical device manufacturers resolutely oppose the unrealistic requirements put forward by the regulatory authorities。Industry thinks，This will postpone the time of product approval。(Author: Wang Di)
