Inclusion of Older Adults in Cancer Clinical Trials
Inclusion of Older Adults in Cancer Clinical Trials guidance provides recommendations regarding the inclusion of older adult patients in clinical trials of drugs for the treatment of cancer. For the purpose of this guidance, older adults are those aged 65 years and older. Specifically, this guidance includes recommendations for including an adequate representation of older […]
Bioavailability Studies Submitted in NDAs or INDs General Considerations
Bioavailability Studies Submitted in NDAs or INDs General Considerations guidance provides recommendations to sponsors and applicants2 submitting bioavailability (BA) information for drug products in investigational new drug applications (INDs), new drug applications (NDAs), and NDA supplements. This guidance contains recommendations on how to meet the BA requirements set forth in 21 CFR part 320 as […]
Electronic Submission of IND Safety Reports Technical Conformance Guide
Electronic Submission of IND Safety Reports Technical Conformance Guide Technical Conformance Guide (Guide) provides specifications, recommendations, and general considerations on how to submit electronic investigational new drug application (IND) safety reports to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). This Guide supplements the draft guidance […]
E2B(R3) The Electronic Transmission of Individual Case Safety Reports Implementation Guide Appendix to the Implementation Guide Backwards and Forwards Compatibility
E2B(R3) The Electronic Transmission of Individual Case Safety Reports Implementation Guide Appendix to the Implementation Guide Backwards and Forwards Compatibility document is an appendix to the Implementation Guide (IG) for the ‘International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Electronic Transmission of Individual Case Safety Reports (ICSRs)’.
Advanced Prostate Cancer: Developing Gonadotropin Releasing Hormone Analogues Guidance for Industry
Advanced Prostate Cancer: Developing Gonadotropin Releasing Hormone Analogues Guidance for Industry guidance describes the Food and Drug Administration’s (FDA’s) current recommendations regarding the overall development program to establish the effectiveness and safety of gonadotropin-releasing hormone (GnRH) analogues for treating advanced prostate cancer. The recommendations in section III.C., Registrational Trial Considerations, apply to drug product […]
Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry
Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a waiver of the requirements of section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379k-1). These recommendations pertain to the format of content […]
Bladder Cancer Developing Drugs and Biologics for Adjuvant Treatment
Bladder Cancer Developing Drugs and Biologics for Adjuvant Treatment guidance provides recommendations to sponsors regarding the development of drugs and biological products regulated by CDER and CBER for the adjuvant treatment of muscle-invasive bladder cancer. The guidance includes recommendations regarding eligibility criteria, choice of comparator, follow-up imaging assessments, determination of disease recurrence, analyses of disease-free […]
Instructions for Use Patient Labeling for Human Prescription Drug and Biological Products Content and Format
Instructions for Use Patient Labeling for Human Prescription Drug and Biological Products Content and Format guidance provides recommendations for developing the content and format of a patient Instructions for Use (IFU) document for human prescription drug and biological products, as well as drug-led or biologic-led combination products submitted under a new drug application (NDA) or […]
Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules
Size, shape and other physical attributes of generic tablets and capsule provide the information to the manufacturers. Tablets and capsules are widely manufactured and prescribed and may provide a number of advantages over other dosage forms, including ease of storage, portability, ease of administration, and accuracy in dosing.