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1. frederick.cancer.gov › sites › defaultPreparing a Meeting Information Package for a Pre-IND (Type B)...

   frederick.cancer.gov › sites › default

   2 Νοε 2020 · A pre-IND meeting is a Type B meeting held between a sponsor and the FDA. The primary purpose of a pre-IND meeting is to discuss safety issues related to the investigational drug; issues related to pre-clinical studies, clinical trial design, and manufacturing; and to identify potential clinical hold issues.

2. www.fda.gov › media › 87621Good Review Practice: Clinical Review of Investigational New Drug...

   www.fda.gov › media › 87621

   This good review practice (GRP) document was prepared to assist FDA clinical review staff in reviewing clinical submissions to an investigational new drug application (IND)

3. ispe.org › initiatives › regulatory-resourcesGMP Audit Checklist for Drug Manufacturers - ISPE

   ispe.org › initiatives › regulatory-resources

   • Αποθηκευμένο αντίγραφο

   The ISPE GMP Audit Checklist is designed to aid in the systematic audit of a facility that manufacturers drug components or finished products.

4. fda.report › media › 72566Guidance for Industry and Review Staff - fda.report

   fda.report › media › 72566

   The purpose of this guidance is to provide sponsors and the review staff in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) with information regarding target product profiles (TPPs). A TPP is a format for a summary of a drug development program2 described in terms of labeling concepts. A TPP can be ...

5. www.fda.gov › drugs › guidance-compliance-regulatory-informationGood Review Practices | GRPs | FDA - U.S. Food and Drug...

   www.fda.gov › drugs › guidance-compliance-regulatory-information

   • Αποθηκευμένο αντίγραφο

   A Good Review Practice, or GRP, is a “documented best practice” within CDER that discusses any aspect related to the process, format, content and/or management of a product review.

6. grants.nih.gov › policy-topics › clinical-trialsProtocol Templates for Clinical Trials | Grants & Funding -...

   grants.nih.gov › policy-topics › clinical-trials

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   16 Αυγ 2024 · NIH applicants can use a template with instructional and sample text to help write clinical protocols for the following types of research: Phase 2 or 3 clinical trials that require Investigational New Drug applications (IND) or Investigational Device Exemption (IDE) applications; Behavioral and social sciences research involving humans

7. www.fda.gov › drugs › information-consumers-and-patients-drugsThe FDA's Drug Review Process: Ensuring Drugs Are Safe and...

   www.fda.gov › drugs › information-consumers-and-patients-drugs

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   The FDA uses postmarket requirement and commitment studies to gather additional information about a product's safety, efficacy, or optimal use. New Drug Application (NDA)--This is the...