FDA Issues Final 21 CFR Part 11 Guidance
As part of a strategic initiative announced last week to modernize the drug approval process, the US Food and Drug Administration released its final guidance for industry on the use of electronic records and signatures.
The guidance document, entitled “Part 11, Electronic Records, Electronic Signatures — Scope and Application” and available at http://www.fda.gov/cder/guidance/5667fnl.htm, clarifies the scope and application of the 21 CFR Part 11 regulation and provides for enforcement discretion in certain areas.
The FDA withdrew its draft guidance for Part 11 in February in order to re-examine provisions of the regulation and consider comments from industry. The final guidance addresses the comments received since that time, including those concerning enforcement discretion, time stamps, and legacy systems.
The final guidance narrows the scope of part 11 in response to the industry’s previous “confusion” about its interpretation. “We want to clarify that the Agency intends to interpret the scope of part 11 narrowly,” the guidance document states. Under the narrow interpretation, “when persons choose to use records in electronic format in place of paper format, part 11 would apply. On the other hand, when persons use computers to generate paper printouts of electronic records, and those paper records meet all the requirements of the applicable predicate rules and persons rely on the paper records to perform their regulated activities…the use of computer systems in the generation of paper records would not trigger part 11.”
The agency also advises industry to determine in advance whether specific records are part 11 records and recommends that those decisions be documented.
The FDA will not enforce part 11 compliance for systems in place prior to August 20, 1997.
The agency said it intends to begin rulemaking to revise Part 11 and provide further clarifications and adjustments consistent with the principles and enforcement policies described in the guidance document, which does not establish legally enforceable responsibilities.
Quorex in Bioinformatics-Based Collaboration with IDEC
Quorex Pharmaceuticals of Carlsbad, Calif., said last week that it had entered into a research collaboration with San Diego-based IDEC Pharmaceuticals centered around its Protein Vision bioinformatics platform, which includes genome annotation, homology modeling, and protein-fold prediction tools.
The goals of the collaboration are to find novel genes encoding proteins for use as therapeutic targets for cancers and inflammatory disorders. Quorex will receive undisclosed up-front and research payments.
“Having successfully applied [Protein Vision] to evaluate bacterial protein targets for our drug discovery programs, we now look forward to collaborating with IDEC on using this powerful platform to find new types of targets outside of anti-infectives,” said Robert Robb, president and CEO of Quorex Pharmaceuticals, in a statement.
Spotfire Signs Four New Distributors
Spotfire last week announced that it had signed four new distributors — CSI, Intrasphere, Protedyne Europe, and Base Consulting — for its DecisionSite software.
The distributors, systems integrators dubbed “value-added resellers” under Spotfire’s alliance partner program, will add DecisionSite to their services portfolios.
U of Illinois Researchers Develop New 3D Structure Algorithm
In the September issue of Acta Crystallographica Section A, researchers from the University of Illinois at Urbana-Champaign report the development of a new algorithm to identify the structures of molecular compounds using X-ray diffraction.
In X-ray diffraction, X-rays bombard a crystallized version of a compound to create 2D patterns of diffracted wave intensities that can be used to reconstruct the 3D object. “A big problem, however, is identifying the phases of the diffracted X-rays from measurements of intensities alone,” said Nikolaos Sahinidis, an Illinois professor of chemical and biomolecular engineering, in a statement. “You know how strong the waves are, but you don't know their phases, which are needed in order to compute the three-dimensional structure.”
Sahinidis and his colleagues overcame the phase problem — currently addressed by trial and error — by reformulating it into an integer-programming problem. “A great variety of combinatorial optimization methods have been developed to solve [integer-programming] problems without explicitly trying all possible combinations of the missing phases,” said Sahinidis. Using the new approach, he said, “we can use off-the-shelf optimization software to rapidly find the correct solution.”
The researchers are currently working to extend the method, which now works for centrally symmetric structures, to non-centrosymmetric structures, which includes most proteins.