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| Mechanism | Process | Center |
|---|---|---|
| Leverage resources by contracts with third parties to perform pathology reviews in support of food safety determinations. | Leveraging | CVM |
| Contract out the review of selected food additive petitions and scientific data packages associated with petitions; review over 600 previously-regulated petitions to identify deficiencies in the petitions. | Leveraging | CFSAN |
| Increase the speed of review of direct food additive petitions by supporting contract staff; create multi-disciplinary teams to help rapidly resolve new and ongoing safety issues related to petition reviews. | Leveraging | CFSAN |
| Contract with the Research Triangle Institute to survey the activities and workloads involved in the petition review process and to develop a computer model of the process that could be used to help streamline the process and determine what resources were needed to meet statutory and other deadlines for petition review. | Leveraging | CFSAN |
| Identify and start development of several Biopharmaceutic Guidances for drugs products with special/unique bioequivalence issues predicted to be the subject of multiple generic drug application submissions. | Guidelines | CDER |
| Eliminate the need for many individual protocol reviews by developing a General BA/BE Guidance for industry. | Guidelines | CDER |
| Expedite and facilitate the approval of new animal drugs by revising the Investigational New Animal Drug procedural regulations. | Guidelines | CVM |
| Improve application processing by implementing ADAA legislation and REGO initiatives including the Veterinary Feed Directive (VFD) by establishing and/or revising regulations and guidance documents. | Guidelines | CVM |
| Finalize the rulemaking creating a premarket notification process for independent generally recognized as safe (GRAS) determinations. | Guidelines | CFSAN |
| Reduce drug development and review time through implementation of additional phases of electronic submission in the investigational new animal drug development process. Increase the scientific basis for prioritizing research and surveillance activities by increasing the number of risk assessments performed regarding animicrobial products to two per year. Maintain a 75 percent level for pre-submission conferences with industry sponsors of new animal drugs. | Electronic Submission | CVM |
| Increase number of reviewers and support staff and the level of training received by reviewers. | Streamlining and Staffing Modifications |
CDER |
| Reorganize to decrease the ratio of Team Leaders to reviewers in order to provide a better mechanism for senior staff to work with newer reviewers. Hire a Medical Officer to facilitate timely review of ANDAs with bioequivalence studies with clinical endpoints. | Streamlining and Staffing Modifications |
CDER |
| Implement a policy on "Substitution of an Alternate Source of the New Drug Substance in Unapproved Abbreviated Applications." | Streamlining and Staffing Modifications |
CDER |
| Remove barriers to industry clinical investigations by acting within 30 days to decide whether newly-submitted information supports the continuation of a human investigation of a drug that the Agency has put on hold. | Streamlining and Staffing Modifications |
CDER |
| Reduce the number of overdue applications and supplemental applications by reassigning reviews in Chemistry review branches with a significant actual or predicted backlog to other branches with lower workloads. | Streamlining and Staffing Modifications |
CDER |
| Implement the Managed Review Process to streamline the process that covers all PDUFA and non-PDUFA original applications and supplements. | Streamlining and Staffing Modifications |
CBER |
| Provide additional research/reviewers for the review of blood applications (PLAs/BLAs, PMAs and 510(k)s); update obsolete requirements for the review of blood applications; develop product standards for the review of blood applications; and convert guidance into regulations for the review of blood applications. | Streamlining and Staffing Modifications |
CBER |
| Reduce the number of manufacturing changes that require Agency pre-approval for biological products. | Streamlining and Staffing Modifications |
CBER |
| Address highly-focused areas of concern such as emergency operations, response to emerging blood-borne diseases, and updating blood regulations through the Blood Action Plan. | Streamlining and Staffing Modifications |
CBER |
| Continue Modular Review for data development, submission, review, and closure in order to break the contents of a PMA into well-delineated modules. Each module is then submitted as soon as the applicant has performed the testing and analyses, even during the IDE process, thus compiling a complete PMA over time. | Streamlining and Staffing Modifications |
CDRH |
| Discontinue the pre-clearance inspection program for class I & II devices. | Streamlining and Staffing Modifications |
CDRH |
| Approve some preamendment PMAs in 180 days using a streamlined process. | Streamlining and Staffing Modifications |
CDRH |
| Expedite the clearance of PMAs by expanding delegation of authority to authorize more people to take sign-off responsibility. | Streamlining and Staffing Modifications |
CDRH |
| Reclassify 39 preamendment PMA devices. | Streamlining and Staffing Modifications |
CDRH |
| Reduce the size and content of 510(k)s by having submitters include Summary Reports of their conformance with Agency guidance documents and any applicable special controls, as well as "Declarations of Conformity" with FDA-recognized conformance standards in their submission. | Streamlining and Staffing Modifications |
CDRH |
| Improve performance in premarket applications for animal drugs and feeds through quality assurance by increasing the number of bioresearch monitoring (data audit) inspections in order to alert the Agency to potential problems and better target resources. | Streamlining and Staffing Modifications |
CVM |
| Reengineer and streamline the animal drug approval process by encouraging presubmission conferences with sponsors, early protocol reviews, and utilization of sponsor-monitoring methods trials; and, the incorporation of phased and direct review of applications. | Streamlining and Staffing Modifications |
CVM |
| Expedite and facilitate the approval of new animal drugs by pursuing REGO initiatives such as expanding the categorical exclusions for environmental assessments and streamlining animal drug regulations. | Streamlining and Staffing Modifications |
CVM |
| Increase the speed of review of direct food additive petitions by conducting timely preapproval and data audit inspections. | Streamlining and Staffing Modifications |
CFSAN |
| Expedite the review of particular classes of additives by using special teams in the Food and Color Additives Petition Program and empowering experienced reviewers to complete the review, thus minimizing or eliminating the need for multiple sign-offs. | Streamlining and Staffing Modifications |
CFSAN |
| Continue implementing a document management system that will make premarket applications and scientific information available to petition reviewers on an on-demand basis. | Streamlining and Staffing Modifications |
CFSAN |
| Simplify the filing process by consolidating 21 different review application forms for biotech drugs, blood, vaccines, and other drugs into one form. | Streamlining and Staffing Modifications |
CDER, CBER |
| Free up Agency resources for other review activities by eliminating the prior approval requirement for promotions in connection with new biologic drugs. | Streamlining and Staffing Modifications |
CDER, CBER |
| Reduce the number of instances where an environmental assessment is required as part of a product application. | Streamlining and Staffing Modifications |
CDER, CBER, CDRH, CFSAN, CVM |
| Continue implementing a workflow tracking system for food and color additive petition reviews. | Computerization | CFSAN |
| Enhance clinical review practices under PDUFA by standardizing review procedures and providing a mechanism for ongoing feedback. | Communication | CDER |
| Begin pilot for streamlined review track for PMAs of devices that are well understood and have established criteria. | Pilot Study | CDRH |
| Initiate pilot to eliminate re-review of final printed labeling where it is either the same as the approved draft labeling or contains only minor changes. | Pilot Study | CDRH |
| Improve performance in premarket application reviews for animal drugs and feeds by hiring additional review staff to improve review times and reduce the backlog; support the necessary academic training for new and existing scientific personnel in order to boost scientific expertise thereby increasing application review efficiency. | Training | CVM |
| Mechanism | Process | Center |
|---|---|---|
| Provide a scientific basis for policy and guidance development on issues of drug product quality and performance by continuing research projects started in FY 1999 under the auspices of the Product Quality Research Initiative (PQRI), a collaboration among FDA, industry and academia. | Leveraging | CDER |
| Leverage resources by bringing academicians on sabbatical for 2-4 week periods to develop and deliver specific scientific courses. | Leveraging | CDER |
| Engage in a broad array of extramural collaborations with industry and academia that impact on product development and review. | Leveraging | CDRH |
| Collaborate with Catholic University to develop information for the evaluation of medical devices used in a Magnetic Resonance Imaging (MRI) environment. | Leveraging | CDRH |
| Leverage resources by providing expertise and knowledge that translates into product and process approvals through the National Center for Food Safety and Technology (NCFST) as a collaborative food safety research consortium and a neutral forum for discussion and solution of food safety/regulatory problems. | Leveraging | CFSAN |
| Increase staff in premarket notification program for food contact substances to provide scientific expertise and support; and, provide education and seek the input for stakeholders through workshops with industry. | Leveraging | CFSAN |
| Shorten drug development time, reduce unnecessary studies, and increase useful information about drugs through collaborations on safety and effectivness which occur with Georgetown University and PhRMA through the Collaboration on Drug Development and Improvement (CDDI). | Leveraging | CDER, CBER |
| Leverage resources and improve FDA's science base for review and other activities by engaging in collaborative research and education programs through the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) composed of CFSAN, CVM, and the University of Maryland. | Leveraging | CVM, CFSAN |
| Conduct research to support the development of scientifically rigorous bioequivalence testing methodologies for nonsystemically absorbed drug products. | Research | CDER |
| Complete projects designed to lead to appropriate policy for applying modern in vitro and ex vivo technology to assess drug metabolism and drug interactions. Develop rational, scientific-based requirements for drug substances, drug products and excipients to ensure a high standard of drug product quality and product performance for making regulatory decisions. | Research | CDER |
| Gain expertise in new and evolving biological products by providing research/reviewers opportunities to conduct regulatory-related research to ensure safe products with the opportunity for fast approval. | Research | CBER |
| Improve performance in premarket applications for animal drugs and feeds through the two studies already planned: "Bioavailability," designed to compare the bioavailability of drugs between production classes of animals, and "Drugs in Milk," designed to detect and investigate the effects of drug residues in milk. | Research | CVM |
| Research whether fewer animal studies or fewer animals within studies are needed in the studies to support new animal drug applications. | Research | CVM |
| To aid in risk assessment, develop a new biological assay to measure genetic change and validate two existing models that predict human genetic damage; conduct molecular epidemiology studies to identify biomarkers of the most frequently occurring cancers in highly susceptible subpopulations; and, validate a model computer-based predictive system to support and expedite product review of estrogenic or estrogen-like compounds. | Research | NCTR |
| Develop and make available predictive systems and methods that speed safety and efficacy assessment by optimizing resource use across FDA in order to strengthen the science base of the Agency. Examples: demonstrate a model toxicity knowledge base to support and expedite product review; develop better biological assays to measure genetic changes and predict human genetic damage; and, predict adverse human response to regulated products using model transgenic systems. | Research | NCTR |
| Strengthen the scientific basis for regulation of compounds of FDA significance by conducting studies that relate how a compound causes damage, to the actual damage. | Research | NCTR |
| Incorporate cutting edge science and technology into the review process to improve the review of notifications for food contact substances. These capabilities include the availability of up-to-date toxicology and chemical databases and appropriate software and hardware to evaluate potential chemical toxicity. | Computerization | CFSAN |
| Strengthen the scientific and analytical basis for regulatory decisions through training revisions to New Employee Orientation, New Reviewers' Workshops, and a new program in the review process for non-reviewers in order to help new hires become productive employees. | Training | CDER |
| Ensure that staff understand and can apply the guidances and regulations for industry before they become final through targeted policy training programs. | Training | CDER |
| Strengthen the scientific and analytical basis for regulatory decisions by developing core competency learning paths to assure that reviewers are trained in areas critical to the drug review process. Hold weekly seminars and scientific rounds to learn specific topics from experts; hold special seminars and workshops to introduce new scientific concepts to the staff; and, provide time for reviewers to develop a specific area of expertise to present courses to their colleagues. | Training | CDER |
| Increase reviewer training in preparation for receiving and reviewing submissions electronically. | Training | CBER |
| Provide regulatory and professional training for reviewers in areas such as: the IND Process, License Application Process, Supplements, and Phase 4 Studies. | Training | CBER |
| Mechanism | Process | Center |
|---|---|---|
| Upgrade the ANDA/Management Information System by contracting for programming and system analysis support. | Leveraging | CDER |
| Complete development of industry guidance required for electronic submission. | Guidelines | CDER |
| Work with firms to facilitate the electronic submission of data (ESD) used to support bioequivalence studies. | Electronic Submission | CDER |
| Achieve electronic receipt and review of all regulatory documents by phases. The first phase has been to develop industry guidance for electronic submission of NDAs. | Electronic Submission | CDER |
| Achieve electronic submission capability for certificates to foreign governments by the end of FY 1999. | Electronic Submission | CDER |
| Establish the capability and capacity to receive and archive abbreviated new drug applications (ANDAs) submitted electronically. | Electronic Submission | CDER |
| Progress toward electronic submission of applications by completing a pilot with up to 25 electronically submitted ANDAs. Industry guidance for electronic ANDAs has been submitted for comment electronically. | Electronic Submission | CDER |
| Expedite the transition toward electronic review; maintain the system for electronic reviews and the database for use by reviewers, or archival submissions for the Entry Validation Application for electronic - structured submissions of bioequivalence data that accompanies generic drug applications. | Electronic Submission | CDER |
| Promote reviewer efficiency by decreasing hardcopy searches for data by accepting chemistry, manufacturing and controls data electronically for beta testing. | Electronic Submission | CDER |
| Design a corporate database and the capability for electronically-submitted INDs; continue analysis, testing, and design activities to accommodate Blood Licensing Applications; and, continue pilot program for electronic IND applications. | Electronic Submission | CBER |
| Prepare a Guidance Manual for Computer Assisted Product License Applications; guidance for electronic submission of application archival copies; case report forms and tabulations, BLA, PLA, or ELA electronic submissions; and, electronic lot release protocols. | Electronic Submission | CBER |
| Pilot a project to permit electronic submission of Notices of Claimed Investigational Exemption (NCIE). | Electronic Submission | CVM |
| Improve application processing time by implementing electronic submission for key components of the investigational new animal drug application process. Develop two phases: Drug Shipment Notices and Notices of Slaughter. | Electronic Submission | CVM |
| Send the review comments/deficiencies to applicants via facsimile; expand FAX to apply to holders of DMFs, contract manufacturers and suppliers who support the firms pursuing the approval of a generic drug. | Streamlining and Staffing Modifications |
CDER |
| Enhance submissions to include electronic microbiology and labeling data and other related initiatives (e.g., online copies of labeling). | Computerization | CDER |
| Process review documents by the implementation of an Electronic Document Management System (EDMS) throughout new and generic drug review divisions. | Computerization | CDER |
| Develop a PC-based tracking system for class III preamendment devices. | Computerization | CDRH |
| Purchase quality hardware, software, and services for the premarket notification program in order to aid efficiency | Computerization | CFSAN |
| Continue to upgrade information and document management systems for the Food and Color Additive petition review program to improve the workflow. | Computerization | CFSAN |
| Allow access to numerous documents 24 hours a day, 7 days a week by implementing the Facts on Demand process. | Communication | CDRH |
| Mechanism | Process | Center |
|---|---|---|
| Focus on helping new drug sponsors establish proof that their products are effective without excessive or redundant studies through implementation of FDA's New Use Initiative. | Leveraging | CDER |
| Reduce or eliminate additional review cycles and move applications to approval quicker by contacting applicants that undergo two or more major deficiency cycles for further discussion. | Leveraging | CDER |
| Release bioequivalence protocols and protocol reviews publicly to reduce the number of post-approval changes requiring chemistry supplements for generic drugs, thus decreasing protocol workload and allowing more time to be spent on application reviews. | Leveraging | CDER |
| Better equip reviewers to perform on-going reviews in new product areas by promoting research and more frequent dialogue between sponsors and FDA staff during early stages of review. | Leveraging | CBER |
| Decrease the amount of data and information required in some PMAs by allowing a declaration of conformity to the Agency's recognized standards. FDA is publishing a list of standards it recognizes. | Leveraging | CDRH |
| Encourage sponsors to submit special and abbreviated 510(k)s because the desired effect on review time will only be achieved if the manufacturers use the new options available to them. | Leveraging | CDRH |
| Speed food and color additive petition design and develop education program explaining the types of studies and safety data required to support petitions. | Leveraging | CFSAN |
| Develop partnerships with government, industry, and academic scientists to conduct studies that demonstrate cross-species comparability and eliminate assumptions necessary for extrapolating laboratory toxicity data to human disease. | Leveraging | NCTR |
| Continue holding meetings and workshops such as: Guidance for Industry--Developing Medical Imaging Drugs and Biologics and Implementation of Biologics License; Elimination of Establishment Product License. | Guidelines | CBER |
| Apply new policies/regulations developed to offer a range of IDE mechanisms that can be tailored to the device, the sponsor's needs and public health. A new guidance document summarizes these mechanisms and provides clear information on available options and how to utilize them. | Guidelines | CDRH |
| Update 10 percent of the animal drug review guidelines which serve as aids to industry in the animal drug review process. | Guidelines | CVM |
| Expedite the review of food safety-related food additives by preparing a guidance document that explains procedures. | Guidelines | CFSAN |
| Develop and publish comprehensive guidelines for petition preparation to speed review of food and color additive petitions. | Guidelines | CFSAN |
| Enhance industry's understanding of the electronic submission process by workshops on the preparation of submissions in electronic format and by the design of an electronic submissions internet page that includes easy-to-understand explanatory material and all information needed to file an IND, NDA, and ANDA. | Electronic Submission | CDER |
| Use a Special 510(k) so that, for many modifications, manufacturers may notify FDA that the product has been changed and is in conformance with the Agency's design control regulations and that it remains safe, effective and substantially equivalent. These applications are smaller than a traditional 510(k) and undergo a prompt review within FDA. | Streamlining and Staffing Modifications |
CDRH |
| Implement Real Time Review to allow rapid decisions on routine PMA supplements with decision making occurring during a meeting or teleconference between the sponsor and review staff. | Streamlining and Staffing Modifications |
CDRH |
| Decrease serious medication errors by making new drug approval information increasingly available; targeted and promoted to specific user groups such as consumers, patients, healthcare practitioners and industry via the Internet. | Computerization | CDER |
| Encourage "exploratory" meetings very early in the premarket review process and continued interactions throughout the review process. | Communication | CDRH |
| Let the manufacturer know what to expect and have control over product development and the review by making mutual and binding agreements with FDA in advance under the PDP alternative to a PMA. | Communication | CDRH |
| Mechanism | Process | Center |
|---|---|---|
| Chair Global Harmonization Task Force to harmonize regulatory requirements to implement the MRA with the EU. | Leveraging | CDRH |
| Recognize and help develop international standards that can be used to satisfy part of the 510(k) requirements. | Leveraging | CDRH |
| Work through ICH to standardize the content and format of information required of drug and biologic manufacturers in their applications. | Leveraging | CDER, CBER |
| Continue to implement the Mutual Recognition Agreement (MRA) with the European Union (EU) to help facilitate transatlantic trade and reduce costs for compliance with regulatory requirements. | Leveraging | CDER, CBER, CDRH, CVM |
| Improve cooperation, coordination, and communication and harmonizing activities with the Device Action Plan | Communication | CBER, CDRH |
| Mechanism | Process | Center |
|---|---|---|
| Reduce the number of 510(k)s submitted each year by 650 by exempting some class I and II devices from the 510(k) process. | Streamlining and Staffing Modifications |
CDRH |
| Propose a way to eliminate class I 510(k)s and provide streamlined alternative review paths for most device modifications and for devices that conform to FDA-recognized standards or FDA guidance documents. | Streamlining and Staffing Modifications |
CDRH |
| Increase the assurance that food derived from animals and animal products is safe for human consumption by increasing the number of antimicrobial product risk assessments by 10 percent. | Research | CVM |
| Develop a capability for using predictive toxicology in prioritizing reviews through the premarket notification program for food contact substances. | Research | CFSAN |
| Focus relevant high-priority research on developing scientific principles and technologies to improve data integrity and reliability, thus reducing uncertainty and speeding availability of new biotechnology, drug products, and device technologies to the public. Complete biochemical and epidemiology studies to define the basis of susceptibility of humans to the toxicity of regulated products. Identify subpopulations of humans at increased risk using molecular markers. Develop modeling tools to predict better risk for cancer, reproductive, developmental, neurological, genetic, and acute toxicological outcomes. Use computer-based predictive systems to evaluate toxins. | Research | NCTR |
To Objective E Report Introduction