Regulation regulatory Reviews

The TAFs are components of TFIID (see table 1.1) and are required for a regulated transcription (review Verriijzer and Tijan 1996, Bmley and Roeder, 1996 ). Thus, the stimulation of transcription by the transcriptional activators Spl and NTF-1 depends upon the presence of specific TAFs in the TFllD complex. The TAFs mediate interactions between the transcriptional activators and the TFllD complex in many cases direct protein-protein interactions could be demonstrated between the activators and TAFs. Some of the TAFs possess additional enzymatic activities which allow them to participate in the regulation of transcription. By this token, the histone acetylase and protein kinase activity of TAFn250 is ascribed a regulatory function in the remodeling of chromatin and in the control of the activity of the basal transcription factors. 

The three product centers that can lead the regulatory review of a neoorgan product include Center for Devices and Radiological Health (CDHR), Center for Biologies Evaluation and Research (CBER), and the Center for Drug Evaluation Research (CDER). CDRH is responsible for regulating those products that are primarily medical devices. A medical device is defined as An instrument, apparatus, implement, machine, contrivance, implant, or other similar or related article, including a component, part, or accessory,... 

It is clear that the FDA considers that the CMC section has the potential to significantly decrease NDA review and approval times. In addition to the issuance of guidance documents and CMC initiatives, the regulations permit the submission of item 4 material 90 to 120 days in advance of other sections of the NDA (21 CFR 314.50(d)(iv)) as a further means of expediting the regulatory review process. 

All medical devices are subject to regulatory review and MA similar to the medicinal products. In the United Kingdom the national regulatory authorities for devices and medicinal products were merged in 2003. However, note that the EMEA, CHMP and COMP do not regulate medical devices, unlike their US equivalents. 

On the other hand, some companies may collect more data than the FDA would require either because they are overly cautious or because the firm needs the data for other reasons (e g., approval in another country or to market the drug more effectively) such firms spend money to pursue research questions not germane to the regulatory review process. Thus, the costs of clinical research in the regulatory phase cannot be attributed in its entirely to regulations. 

Largely in response to the AIDS epidemic and the regulatory reform movement of the 1980s, the FDA issued new regulations, in 1988, known as Subpart E, that substantially alter the research and regulatory review process for drugs to treat... 

It is well recognized by industry and regulatory agencies alike that review and approval of the application has the potential to be a long and difficult process. In the United States and the EU, regulations have been enacted which seek to limit the duration of the majority of regulatory reviews, provided the information contained in the application meets minimum standards of completeness and acceptability. 

---