Regulatory Affairs
Legal Basis for Marketing Authorization in the EEA
Navigating the regulatory landscape for drug approval in the European Economic Area (EEA) can be complex. There are multiple legal pathways, each with its own requirements, especially around clinical studies. Here’s a quick snapshot: Full Applications (Article 8(3) of Directive 2001/83/EC) require comprehensive clinical data for new products. Generic Applications ... Read More
FDA NDA Classification Codes
Understanding New Drug Application (NDA) Classification Codes is crucial for setting clear regulatory and development timelines. These codes help the FDA categorize new drugs based on their relationship to previously approved therapies. The numerous acronyms used by the FDA, along with their distinct meanings, can be quite confusing. Beyond its ... Read More
Differences Between eCTD and ACTD Dossier
eCTD (Electronic Common Technical Document) ACTD (ASEAN Common Technical Dossier) Key Differences Read also: Resource Person: KABYA PRATAP ROYAL
Understanding the FDA 483 Warning Letter
FDA Form 483 = Official notification issued at the conclusion of a facility inspection when FDA investigators identify conditions that may violate the FD&C Act and related regulations. Consists of observations regarding practices that may lead to the adulteration of products or pose health risks. Navigating the FDA 483 Warning ... Read More
A Brief Overview of the 505 Regulatory Pathways
The FDA recognizes three primary pathways for the approval of new drugs and abbreviated new drug applications (ANDA): the 505(b)(1) NDA, 505(j) ANDA, and 505(b)(2) NDA. Each pathway serves a distinct purpose in the drug approval process. 505(b)(1) NDAThe 505(b)(1) NDA is a comprehensive application that relies entirely on original ... Read More
505(b)(2) Submission Process
The 505(b)(2) submission journey involves four crucial steps: candidate identification, candidate assessment, product planning, and the pre-IND meeting. Candidate IdentificationThe first step involves selecting drug products compatible with the 505(b)(2) pathway, a crucial action that mitigates the risk of failure. It typically involves a few nonclinical studies. During Phase 1, ... Read More
Whether to Submit an ANDA or 505(b)(2) Application
(1) A “stand-alone NDA” is an application submitted under section 505(b)(1) and approved under section 505(c) of the FD&C Act that contains full reports of investigations of safety and effectiveness that were conducted by or for the applicant or for which the applicant has a right of reference or use. ... Read More
FDA Queries Related to Drug Substances in the CMC
There are few common queries related to drug substances in the CMC (Chemistry, Manufacturing, and Controls) section. Here’s an example: 3.2. S DRUG SUBSTANCE3.2. S.1 General Information 3.2. S.1.1: Nomenclature SectionQueries: 1. USAN, BAN, IUPAC, names, CAS not provided until. 3.2. S.1.2: Structure Section Queries:Stereochemistry, Isomerism structure and discussion on ... Read More
Site Master File in Pharmaceutical Industry
In the world of pharmaceutical manufacturing, understanding and maintaining high standards of quality is not just important, it’s imperative. A key element in this quality assurance landscape is the Site Master File (SMF), but what is it? An SMF is a comprehensive document that provides detailed information about the production ... Read More
Differences in Filing for Drug Master File in US, Canada and Europe
In Europe, when filing for a Drug Master File (DMF), the process revolves around stringent regulatory requirements set by the European Medicines Agency (EMA). In the United States, filing for a Drug Master File (DMF) is governed by the Food and Drug Administration (FDA), which has its unique set of ... Read More