Regulatory information, transfer

Essentially, the eCTD is a transport format for facilitating electronic submissions. The eCTD serves as an interface for industry-to-agency transfer of regulatory information while at the same time, taking into consideration the facilitation of the creation, review, life cycle management, and archival of the electronic submission. The eCTD specification lists the criteria that will make an electronic submission technically valid. The eCTD represents a major advance in the submission of information to support an NDA. In the future, companies may be able to send their submissions to several regulatory authorities simultaneously with a single stroke of a computer key. 

The development of electronic standards for the transfer of regulatory information. ... 

Information transfer must take place between industry and government on a continual basis and must start at the very beginning of a regulatory movement. 

ICH Recommendations for Electronic Standards for the Transfer of Regulatory Information (ESTRI) (effective March and July... 

Mechanisms should exist to allow for transfer of information, including quality or regulatory information, between a manufacturer and a customer, as well as the transfer of information to the relevant regulatory authority as required. 

Regulatory Information Sources. For information on the current status of air-quality regulations and related background documents, see the EPA Office of Air Quality Planning and Standards (OAQPS) Technology Transfer Network (T IN) web site at www.epa.gov/ttn/. 

The database is continually updated by the staff StMLU and TUV and used in the daily decision making. So the information transfer to the staff in both the company and the regulatory body is guaranteed. 

The mechanisms that regulate protein biosynthesis must be such that appropriate concentrations and types of enzymes can be synthesized in response to extracellular conditions. Furthermore, the protein biosynthetic mechanism is of such paramount importance to life, and so complex, that we would expect multiple controls to exist. This expectation is completely justified—such controls being found at all levels of information transfer required in the protein biosynthetic mechanism. In order to maintain a balance between the component parts, the regulatory mechanisms must control the rates of protein synthesis, utilization, and degradation. Of course, it need hardly be pointed out that, while nucleic acids provide the information for protein synthesis, enzymes mediate the biosynthetic processes themselves. 

Seeing the success of the UNAMAP BBS, EPA s Office of Air Quality Planning and Standards started a BBS for information on regulatory models in June 1989. This has expanded to a BBS called TTN, Technology Transfer Network. This BBS, in Durham, NC, is reached on (919) 541-5742 and the system operator on (919) 541-5384. A part of this BBS called SCRAM, Support Center for Regulatory Air Models, contains model FORTRAN codes, model executable codes for use on personal computers, meteorological data, and in some cases model user s guides. Much of the information is downloaded in "packed" form, and software to unpack the files must also be downloaded from the bulletin board. 

From these selected references and others, we have confidence that the FDA and USP accept automation in general, and automated dissolution in particular. The references confirm the importance of maintaining the same basic chemistry and adhering to compendium design as closely as possible. This is not only a regulatory consideration but also one of practicality. It is extremely important that methods can be successfully transferred to other sites and apparatus (automated or otherwise). With this information we may proceed with our functional design of an automated dissolution system. 

Translation of the information encoded in DNA, expressed as a particular nucleotide sequence, into a protein, expressed as an amino acid sequence, depends on the genetic code. In this code, sequences of three nucleotides (termed a codon) represent one of the 20 amino acids that compose the protein molecule. Because there are 64 codons which can be constructed for the four different bases, and only 20 different amino acids that are coded for, several amino acids may be coded for by more than one codon. There are also three codons, called stop codons, that terminate the transfer of information. Furthermore, although all cells contain the same complement of genes, certain cells (for example, the neurons) have specialized genes that encode specific proteins for the synthesis of specific transmitters. The expression of such genes is under the control of regulatory proteins called transcription factors which control the transcription of mRNAs from the genes they control. 

S Additional information <72> (<72>, mediates the transfer of phosphate to the SpoOA and SpoOF sporulation regulatory proteins. SpoOF protein is a much better phosphoreceptor for this kinase than SpoOA protein in vitro [107]) [107]... 

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