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Regulations, Guidances, and Manual of Policies and Procedures (MaPPs)
The
Federal Food, Drug, and Cosmetic Act, Chapter V, Drugs and Devices.
The Federal Food, Drug, and Cosmetic Act (the Act), was signed into law in 1938 and
has been amended several times since; enforcement accounts for about 90 percent of FDA's workload.
This statue and its amendments provide for the regulation of foods, human and
animal drugs, medicated animal feeds, medical devices, and cosmetics.
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21 Code of Federal Regulations
- 21 Code of Federal
Regulations Section 310.305 This section of the code is titled; "Records and reports concerning adverse
drug experiences on marketed prescription drugs for human use without approved
new drug applications." It addresses the type of reports that are required to be
submitted to the Agency (FDA) when an adverse reaction occurs with a drug that
is not required to have an NDA (pre-1938 marketed drugs).
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Code of Federal Regulations Section 314.80 This section of the code is titled; "Postmarketing reporting of adverse
drug experiences." It addresses the type of reports that are required to be
submitted to the Agency (FDA) when an adverse reaction occurs with a drug that
is marketed under an approved New Drug Application.
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Code of Federal Regulations Section 314.90 This section of the code is
titled "Applications for
FDA approval to market a new drug: Waivers," and addresses waivers to
requirements under Section 314.50 through 314.81.
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Code of Federal Regulations Section 314.98 This section of the code
is titled, "Postmarketing Reports." It addresses the
requirements regarding the reporting and recordkeeping of adverse drug
experiences for abbreviated new drug applications.
- 21 Code of Federal Regulations, Section 201.10(c)
This section of the code is titled "Labeling: Drugs;
statement of ingredients," and addresses some reasons the labeling
of a drug may be misleading.
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Code of Federal Regulations Part 208 This part of the code is
titled, "Medication Guides for Prescription Drug Products." It
addresses the general provisions and general requirements for Medication
Guides.
Clinical/Medical
Electronic Submissions (draft)
International Conference on Harmonisation, Efficacy
Procedural (Draft)
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