From 01 September 2019, eCTD Format For Dossier Submission Will Be Mandatory For The Health Canada

Health Canada has been accepting regulatory activities in eCTD format since 2004. Now Health Canada will accept dossiers in eCTD format only from 01 September 2019 for the following applications. (more…)

FDA has announced User Fee for FY2020

The US Food and Drug Administration (FDA) has published the user fee amounts it will collect in FY2020 from the manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices and outsourcing facilities that produce compounded drugs.

The below table shows the detail list of fees for each program: (more…)

Mutual Agreement on GMP Inspections Fully Implement By US and EU

The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) on 12th July said they have now fully implemented a Mutual Agreement that will allow member state regulators and FDA to mutually rely on each other’s good manufacturing practice (GMP) inspections of drug facilities. (more…)

Inactive Ingredient Database: A Draft Guidance by FDA

The US Food and Drug Administration (FDA) issued a draft guidance for public consultation providing recommendations for drug makers on using the agency’s inactive ingredient database (IID) during drug development.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FDA released Draft guidance provides recommendations for developing the content and format of an Instructions for Use (IFU) document for human prescription drug and biological products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The US Food and Drug Administration (FDA) released one draft guidance on the content and format of the “Drug Abuse and Dependence” section of labeling.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…)