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Answer the Questions. REGULATORY AFFIARS

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1.Can you find any data on BLA review times? Can you find any current or historical information related to deficiencies found in BLA’s? Please cite your references.
2.read colleague’s opinion and Write your comments .
The BLA is regulated under 21 CFR 600 – 680. In a general search of the FDA website regarding data on BLA review times, very vague information regarding current BLA metrics came up. Per FDA’s “Agency Emergency Processing Under the Office of Management and Budget Review; Certification to Accompany Drug Biological Product, and Device Applications or Submissions” issued in 2007 in the Federal Register, CDER and CBER received 214 new drug applications/biologics license applications and resubmissions including 8,535 NDA/BLA amendments in the fiscal year of 2004. Based on the information in the Federal Register, review time for NDAs, BLAs, PMAs, HDEs, and 501(k)s approximately 45 minutes on average would be needed per response for certifications which accompanied their respective submissions. Estimated reporting burdens based on the type of application, supplement, or resubmission is also available. CDER also provides a vague list of NDA and BLA approvals that are priority and standard between the fiscal years of 1993 through 2008, but there is no specific discernment between an NDA or BLA approvals. The approval times provide the median FDA review time and the median total approval time in months. The FDA also provides a list of BLA approvals by calendar year, within the last 5 years it looks like approximately 70 or so BLAs were approved between 2010 through 2014. Some of the gaps may be the restructuring of the organization and what CBER manages versus CDER. PDUFA V will be addressing many of the gaps from previous metrics captured moving forward from 2013 through 2017, promoting more opportunities for increased communications between the FDA and any potential applicants, FDA’s review clock will begin after the 60 day administrative filing review program. Proposed review goals are documented in the PDUFA reauthorization performance goals and procedures fiscal years 2013 through 2017.


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