The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Drug Master Files.” Once finalized, this guidance will provide FDA’s current thinking on drug master files (DMFs), which are submissions to FDA that may be used to provide confidential, detailed information about facilities, processes, or articles […]
The US Food and Drug Administration (FDA) finalized guidance providing advice to drug and biologic sponsors looking to apply for Prescription Drug User Fee Act (PDUFA) fee waivers, reductions and refunds.
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has revised its drug registration guide. The updated document addresses quality control, inspections and other steps in the drug registration process and features product-specific labeling requirements for eight more therapies than its predecessor.
China’s Center for Drug Evaluation (CDE) has released draft information regarding the future of electronic common technical document (eCTD) submissions in China. While things may change between this draft information and the final specification.
The eCTD is mandatory for ALL CEP applications to EDQM including notifications, revision, renewal and new applications from 1 January 2020.
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.
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:
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.
The US Food and Drug Administration (FDA) issued a draft guidance for public consultation providing recommendations for drug makers on using the agency’s inactive ingredient database (IID) during drug development.
FDA released Draft guidance provides recommendations for developing the content and format of an Instructions for Use (IFU) document for human prescription drug and biological products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 […]