Regulatory Affairs

505(b)(2) Submission Process

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

Whether to Submit an ANDA or 505(b)(2) Application

(1) A โ€œstand-alone NDAโ€ 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

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. Hereโ€™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

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

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
Key Steps for Successfully Replying to Dossier Queries

Key Steps for Successfully Replying to Dossier Queries

Here’s a strategy chart outlining the key steps for successfully replying to dossier queries. Understand the Inquiry: Review Dossier Contents: Identify Response Components: Organize Response Structure: Gather Supporting Information: Compliance Check: Clarity and Conciseness: Transparency and Honesty: Quality Assurance: Timely Submission: Follow-Up Protocol: Documentation and Recordkeeping: Read also: Resource Person: ... Read More
Comparison Between Generic and Branded Product Regulatory Filings

Comparison Between Generic and Branded Product Regulatory Filings

Generic and branded pharmaceutical companies both undergo regulatory filings as part of the drug approval process. While the overarching goal is to ensure safety and efficacy, there are distinct differences in the regulatory requirements and processes for generic versus branded medications. Regulatory Requirements Generic: Branded: Filing Process Generic: Branded: Timelines ... Read More
ASEAN Common Technical Document (ACTD)

ASEAN Common Technical Document (ACTD)

It is a submission format for dossiers used in most ASEAN countries (Association of South-East Asian Nations). The main aim of ACTD is to regulate the pharmaceutical regulations of the ASEAN member countries to complement and facilitate the objective of AFTA (ASEAN Free Trade Area), particularly, the elimination of technical ... Read More
Estimated Time Frames for Obtaining FDA Authorization

Estimated Time Frames for Obtaining FDA Authorization

๐—•๐—ถ๐—ผ๐—น๐—ผ๐—ด๐—ถ๐—ฐ๐˜€ The approval timeline for a biologic can vary depending on the complexity of the product and the data required to support its safety and effectiveness. ๐—ฃ๐—ฟ๐—ฒ-๐—œ๐—ก๐—— ๐—ฑ๐—ฒ๐˜ƒ๐—ฒ๐—น๐—ผ๐—ฝ๐—บ๐—ฒ๐—ป๐˜: 1-2 years๐—œ๐—ก๐——: 1-2 years๐—–๐—น๐—ถ๐—ป๐—ถ๐—ฐ๐—ฎ๐—น ๐˜๐—ฟ๐—ถ๐—ฎ๐—น๐˜€: 3-7 years๐—•๐—Ÿ๐—” ๐˜€๐˜‚๐—ฏ๐—บ๐—ถ๐˜€๐˜€๐—ถ๐—ผ๐—ป: 6 months๐—™๐——๐—” ๐—ฟ๐—ฒ๐˜ƒ๐—ถ๐—ฒ๐˜„: 6-12 months๐—ง๐—ผ๐˜๐—ฎ๐—น ๐—ฎ๐—ฝ๐—ฝ๐—ฟ๐—ผ๐˜ƒ๐—ฎ๐—น ๐˜๐—ถ๐—บ๐—ฒ: 5-10 years ๐—•๐—ถ๐—ผ๐˜€๐—ถ๐—บ๐—ถ๐—น๐—ฎ๐—ฟ๐˜€ The approval timeline for ... Read More
FDA Requirements For OTC Drugs

FDA Requirements For OTC Drugs

An over-the-counter (OTC) product can be described as a medicine available for self-medication that does not require a doctorโ€™s prescription. Self-medication is a common treatment of many routine health problems such as headaches, allergies, and skin conditions. OTC drugs are designed, labeled, and approved by various regulatory agencies around the ... Read More
Drug Development and Approval Process | Part III

Drug Development and Approval Process | Part III

When studying a new drug, it can sometimes take many years to learn whether a drug actually provides a real effect on how a patient survives, feels, or functions. A positive therapeutic effect that is clinically meaningful in the context of a given disease is known as clinical benefit. Mindful ... Read More