Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry this document given by FDA. The Drug Supply Chain Security Act (DSCSA) (Title II of Public Law 113-54) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to establish requirements for product tracing, verification, […]
Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products
Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products guidance describes FDA’s current recommendations regarding adjusting for covariates in the statistical analysis of randomized clinical trials in drug development programs. This guidance provides recommendations for the use of covariates in the analysis of randomized, parallel group clinical trials that are applicable to […]
Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry
Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry guidance is to help sponsors of investigational new drug (IND) applications and applicants of biologic license applications (BLAs) determine the need for drug-drug interaction (DDI) studies for a therapeutic protein by providing recommendations for a systematic, risk-based approach. For this guidance, a therapeutic protein refers to […]
Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment
Chronic Rhinosinusitis With Nasal Polyps: Developing Drugs for Treatment. The purpose of this guidance is to assist sponsors in the development of drugs or biological products for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP). Specifically, this guidance addresses FDA’s current thinking regarding trial population and design, effectiveness, statistical analysis, and safety for drugs […]
Waivers Exceptions and Exemptions from the Requirements of Section 582 of the Federal Food Drug and Cosmetic Act
Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act. This guidance describes the process an authorized trading partner or other stakeholder should use to request a waiver, exception, or exemption from the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as well as […]
Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act
Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act guidance is intended to assist supply chain stakeholders, particularly trading partners, with requirements for enhanced drug distribution security at the package level under section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1), as added […]
Electronic Submission Template for Medical Device 510(k) Submissions
Electronic Submission Template for Medical Device 510(k) Submissions guidance provides the standards for the submission of premarket notification (510(k)) submissions by electronic format, a timetable for establishment of these standards, and criteria for waivers of and exemptions from the requirements to meet a statutory requirement. This guidance is also intended to represent one of several […]
Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol
Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol. This guidance is intended to alert pharmaceutical manufacturers and pharmacists in State-licensed pharmacies or Federal facilities who engage in drug compounding to the potential public health hazard of alcohol (ethyl alcohol or ethanol) or isopropyl alcohol contaminated with or substituted with methanol. During the […]
Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements
Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements guidance addresses certain requirements that apply to blood establishments that collect blood and blood components, including Source Plasma. Specifically, the guidance explains the conditions under which FDA does not intend to take regulatory action for a blood establishment’s […]