Regulatory review

To ensure that regulatory review, compliance, and inspection policies are based on state-of the-art pharmaceutical science. 

U.S. EPA, Draft Iron and Steel Regulatory Review, 40 CFR Part 420, Effluent Limitations Guidelines and Standards for the Iron and Steel Manufacturing Point Source Category, EPA 821-R-95-037, U.S. EPA, Washington, DC, 1995. 

ANTEC 2003. Proceedings of the 61st SPE Annual Conference held Nashville, Tn., 4th-8thMay 2003. Brookfield, Ct., SPE, 2003, Volume 1-Processing Session W6-Vmyl I, p.3080-2, CD-ROM, 012 ORGANOTTN STABILIZERS GLOBAL REGULATORY REVIEW Johnson R W Rohm Haas Co. 

There are many details of a safe harbor that would have to be worked out, including the format for the safe-harbor presentation of data, the process for submitting such data, and the procedure for regulatory review. 

The Council encourages further development of FDA s error prevention analysis efforts to provide consistent regulatory review of product labeling and packaging relative to the error-prone aspects of their design. 

DiMasi JA, Manocchia M. Initiatives to speed new drug development and regulatory review the impact of FDA-sponsor conferences. Drug Info J 1997 31 771-8. 

The basis of the regulatory review and the clinical trial system is established in 1977 after... 

Responsibility for regulatory review has been passed to an Incorporated Administrative Agency, the Pharmaceutical and Medical Devices Agency (PMDA). PMDA also intensively checks applications for GCP compliance and reliability compliance. Another important role of PMDA includes an advice to sponsors on clinical trials and on which result can be submitted at the time of a new drug application. 

Currently, there are closure Resource Conservation Recovery Act (RCRA) permit modifications awaiting ERA approval. To date, there have been no delays due to approval of permit modifications, but they could occur in the future. Permit modifications need to be identified sufficiently early to allow time for regulatory reviews, public comment, resolution of comments, and incorporation of changes into the applicable engineering change proposals (ECPs), work orders, or other management control documents. 

These permit modifications were submitted to EPA from April 2000 through July 2000. Currently, two permit modifications are partially approved and awaiting final EPA approval. The remaining four permit modifications have been approved. Permit modifications need to be identified with sufficient lead time to allow EPA regulatory review, public comment, and the resolution of any EPA and/or public comments. Delays in the approval of permit modifications can delay the completion of closure. If the Army elects to implement an ECP prior to EPA approval, it does so at its own financial and/or schedule risk. Potential delays and... 

CH2MHILL. 1998. Environmental Closure Plan Outline and Regulatory Review for USACAP Operations Johnston Island, Johnson Atoll. July. Prepared for U.S. Army Corps of Engineers, Pacific Ocean Division. Honolulu, Hi. CH2MHILL. 

Characterization management plan Concurrent coprocessing Regulatory reviews ... 

While the efficiency of the NDA and BLA review process has greatly improved, dramatically decreasing the time for regulatory review, the same cannot be said for overall drug development time, from identification of a new drug candidate to NDA or BLA submission, which has resisted the anticipated streamlining effects of new technologies and efficiencies. 

Sensabaugh, S. M., A Primer on CBER s Regulatory Review Structure and Process, Drug Information Journal, No. 32, 1998, pp. 1011-1030. 

Huang S-M, Temple R Is this the drug or dose for you Impact and consideration of ethnic factors in global drug development, regulatory review, and clinical practice. Clin Pharmacol Ther 2008 84 287 or http //www.fda.gov/cder/genomics/publications.htm... 

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