Subsection F – Availability of specific categories of records No. 20,100 – Applicability; Reference to other rules. No. 20.101 – Administrative documents. No. 20.102 – Minutes of Execution of the Tribunal. No. 20.103 – Correspondence. No.
20.104 – Summary of oral discussions. 20.105 – Trials and research conducted by or with funding from the Food and Drug Administration. 20.106 – Studies and reports prepared by or with funds from the Food and Drug Administration. No. 20.107 – Food and Medicine Management Manuals. 20.108 – Agreements between the Food and Drug Administration and other departments, agencies and organizations. 20.109 – Contracted data and information. No. 20.110 – Food and Drug Administration personnel data and information. No. 20.111 – Data and information voluntarily transmitted to the Food and Drug Administration. 20.112 – Voluntary Drug Experience Reports submitted by doctors and hospitals.
20.113 – Voluntary Product Error Reports. No. 20.114 – Data and information provided through quality assurance cooperation agreements. 20.115 – Product codes for production or sales data. No. 20.116 – Information on registration and list of medicines and devices. No. 20.117 – New information on drugs. No.
20.118 – Advisory Committee Records. 20.119 – Lists of names and addresses. No. 20.120 – Registrations in the public premises of the Food and Drug Administration. The advisory committees independently advise the FDA and make recommendations on scientific and technical issues related to the development and evaluation of Agency-regulated products. The CDER requires consultation with advisory committees on a wide range of issues, including various aspects of clinical reviews and applications for drug marketing authorization. The members of the committee are scientific experts such as doctors and statisticians, as well as representatives of the public, including patients. Although agency committees make recommendations, final decisions are made by the FDA. These documents are approved instructions for internal practices and procedures followed by CDER staff to standardize the new drug control process and other activities.
Mapps also define external activities. All POPs are available to the public to better understand guidelines, office definitions, staff responsibility and procedures. Subsection B – General Policy 20.20 – Food and Drug Administration Registration Publication Directive. No. 20.21 – Uniform access to records. No. 20.22 – Partial Disclosure of Records. 20.23 – Requirement of existing registrations. No.
20.24 – Creating new records. No. 20.25 – Retroactive application of the rules. 20.26 – Indices of certain data sets. No. 20.27 – Filing of records classified as confidential. No. 20.28 – Determination of Confidentiality by the Food and Drug Administration.