Pre Launch Activities Importation Requests (PLAIR)
Pre Launch Activities Importation Requests (PLAIR) guidance finalizes the July 2013 draft guidance Pre-Launch Activities Importation Requests (PLAIR), which describes the FDA’s policy regarding requests for the importation of unapproved finished dosage form drug products by an applicant preparing the product for U.S. market launch based on anticipated approval of a pending new drug application […]
Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry
Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry guidance provides recommendations to sponsors of drugs or biologics for the treatment of cancer regarding the design and conduct of clinical trials intended to simultaneously evaluate more than one investigational drug and/or more than one cancer type within the […]
Use in First In Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry
Use in First In Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry guidance is to provide advice to sponsors regarding the design and conduct of first-in-human (FIH) clinical trials intended to efficiently expedite the clinical development of oncology drugs, including biological products, through multiple expansion cohort trial designs. These […]
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 […]