Inactive Ingredient Database: A Draft Guidance by FDA

The US Food and Drug Administration (FDA) issued a draft guidance for public consultation providing recommendations for drug makers on using the agency’s inactive ingredient database (IID) during drug development. (more…)

FDA’s Draft Guideline for Instructions for Use – Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic- Device Combination Products – Content and Format

FDA released Draft guidance provides recommendations for developing the content and format of an Instructions for Use (IFU) document for human prescription drug and biological products and drug-device or biologic-device combination products submitted under a new drug application (NDA) or a biologics license application (BLA). The IFU is developed by applicants for patients who use drug products that have complicated or detailed patient-use instructions. (more…)

FDA’s Draft Guideline for Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products

The US Food and Drug Administration (FDA) released one draft guidance on the content and format of the “Drug Abuse and Dependence” section of labeling.

This guidance is intended to assist applicants in writing the DRUG ABUSE AND DEPENDENCE section of labeling, as described in the regulations for the content and format of labeling for human prescription drug and biological products (21 CFR 201.57(c)(10)). This guidance applies to: (more…)