FDA approved 35 innovative new drugs in fiscal year 2011

Source: the 2011-11-07 report compiled by the China Council for the promotion of drugs shows that the United States quickly approved safe and effective drugs ahead of other countries The FDA has approved 35 new drugs in the past 12 months This is the highest number approved in the past decade, after 2009 (37) Many drugs have made important progress for patients, including: two new drugs for hepatitis C; one for advanced prostate cancer; the first new drug for Hodgkin's lymphoma in 30 years and the first new drug for lupus in 50 years In today's report - innovative drugs approved in FY2011, FDA provides detailed information on how regulatory authorities use the power of accelerated approval under the prescription drug user fee Act (PDUFA), adopt a flexible attitude towards clinical trial requirements and data collection, and accelerate approval in the financial year ending September 30, 2011 Innovative drugs and keep the safety standards of approved drugs unchanged The report shows that FDA approval time in the United States is faster than that of its global counterparts Of the 35 approved drugs, 24 were in the United States earlier than any other country in the world and earlier than the European Union The United States continues to maintain its leading trend of first approval of new drugs in the world "The approval of 35 important drugs in a year shows that the pharmaceutical industry and FDA are doing well, and we will continue to use every possible resource to get new treatments for patients." Dr Margaret Hamburg, food and drug Commissioner, said, "we are committed to working with the pharmaceutical industry to promote scientific and innovative research that produces breakthrough treatments and to ensure that our country has the capacity to meet the public health challenges of the 21st century." Among the new drugs approved in FY2011, there are some remarkable improvements in patient care and approved efficiency: two drugs - one for melanoma and one for lung cancer - are major breakthroughs in individualized medicine They each have a diagnostic reagent to help identify whether the drug is of the greatest benefit to the patient Seven new drugs provide great improvement for cancer treatment Almost half of the drugs were judged to be significantly more effective than existing therapies for heart attacks, stroke, and kidney transplant rejection 10 "orphan" disease drugs, because patients with these diseases often lack any treatment, such as treatment of hereditary angioedema Almost half (16) new drugs were approved through the "priority review" procedure, for which FDA has six months to complete the safety and effectiveness review Two thirds of new drug approvals are completed in a single review cycle, which means that the manufacturer provides sufficient evidence, so the FDA does not need more new information to make the application pass the review The three drugs were approved through "accelerated approval", that is, FDA quickly approved important new drugs that are safe and effective in medicine and confirmed their clinical benefits according to post marketing research procedures For example, corifact, the first drug approved to treat rare blood clotting disorders, was approved under this procedure 34 of the 35 drugs were approved within the target review time agreed by PDUFA legal pharmaceutical industry or in advance, including 3 cancer drugs approved by FDA within less than 6 months In 1992, the U.S Congress enacted the prescription drug user fee act to ensure that FDA has necessary resources for the safety and timely review of new drugs, as well as efforts to increase drug safety PDUFA's current legislative authority expires on September 30, 2012 Janet Woodcock, M.D., director of the FDA Center for drug evaluation and research, said: "before the implementation of PDUFA, patients in the United States waited for new drugs for a long time before getting them elsewhere." "As a result of the implementation of the user fee method, FDA has maintained a high standard of safety and effectiveness of new drug review while patients in the United States are getting new drugs quickly." In October 2011, FDA released a new plan to promote Biomedical Innovation: assist in new product development, especially small entrepreneurial companies, to research and improve products for patients In another move, the FDA also released a drug shortage report this week According to the president's instruction, the agency will work with the Department of justice to prevent price inflation to carry out early notification of drug shortage, so as to expand the action to solve the current drug shortage Original link: http://www.fda.gov/aboutfda/reportsmanualsforms/reports/ucm276385.htm