FDA
US FDA Inspection and SMEs Role
Before Inspection During Inspection Key Phrases Best Practices Common FDA Inspection Questions After Inspection Additional Tips By following these guidelines, SMEs can effectively communicate with US FDA inspectors. Read also: Resource Person: Rajesh Jain
Clinical Trials with Decentralized Elements
The U.S. Food and Drug Administration (FDA) issued final guidance titled โConducting Clinical Trials with Decentralized Elements.โ This guidance provides recommendations for sponsors, investigators, and other stakeholders on implementing decentralized elements in clinical trials. A decentralized clinical trial (DCT) is defined as a trial where trial-related activities occur outside traditional ... 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. Hereโs 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
ANDA Suitability Petition Vs 505(b)(2)
Drug Price Competition and Patent Term Restoration Act, commonly known as the Hatch-Waxman amendments, was enacted in 1984 to streamline the approval process for generic drugs. Under this law, generic drug manufacturers can file an ANDA to seek approval for a generic version of a previously approved brand-name drug, also ... Read More
Key Steps to Minimize the Chances of Getting a RTR from FDA
I am reaching out today to share important information that can help us circumvent any potential issues with Abbreviated New Drug Applications (ANDAs) filed with the FDA. ANDAs are essential for the marketing of generic drugs, and therefore receiving a Refusal to Receive (RTR) can significantly delay approvals. From detailed ... Read More
ANDA Submission and Common Deficiencies
In the world of pharmaceuticals, understanding the ANDA (Abbreviated New Drug Application) submission process is crucial for drug manufacturers seeking approval to market generic drugs. Evaluation Procedure The Food and Drug Administration (FDA) thoroughly evaluates each submitted ANDA to determine if it can be received for review. The concept of ... Read More
Effective Design of Clinical Trials | FDA
The 1962 FD&C Act Prior to 1962, drug safety was the primary concern, but the act revolutionized the landscape by demanding substantial evidence of a drug’s effectiveness. This shift led to the requirement of “adequate and well-controlled studies” – a cornerstone of modern clinical research. ๐๐ฑ๐ฒ๐พ๐๐ฎ๐๐ฒ ๐ฎ๐ป๐ฑ ๐ช๐ฒ๐น๐น-๐๐ผ๐ป๐๐ฟ๐ผ๐น๐น๐ฒ๐ฑ ๐ฆ๐๐๐ฑ๐ถ๐ฒ๐: ๐ง๐ต๐ฒ ... Read More
Explanation of FDA Designations
Navigating the complex landscape of clinical trials can be overwhelming, especially when it comes to understanding the various designations put forth by the U.S. Food and Drug Administration (FDA). Here’s a breakdown of some crucial designations: Standard Designation: Standard designation is the typical pathway for drug development, involving preclinical studies ... Read More
Amendments vs Supplements | USFDA
Both amendments and supplements are important tools in the USFDA’s regulatory process with some key differences. Amendment Initiated by the company or requested by the USFDA to make a change to an unapproved application/PAS/tentatively approved application. There are three categories of amendments: major, minor, and unsolicited. Major amendments are changes ... Read More
Estimated Time Frames for Obtaining FDA Authorization
๐๐ถ๐ผ๐น๐ผ๐ด๐ถ๐ฐ๐ 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. ๐ฃ๐ฟ๐ฒ-๐๐ก๐ ๐ฑ๐ฒ๐๐ฒ๐น๐ผ๐ฝ๐บ๐ฒ๐ป๐: 1-2 years๐๐ก๐: 1-2 years๐๐น๐ถ๐ป๐ถ๐ฐ๐ฎ๐น ๐๐ฟ๐ถ๐ฎ๐น๐: 3-7 years๐๐๐ ๐๐๐ฏ๐บ๐ถ๐๐๐ถ๐ผ๐ป: 6 months๐๐๐ ๐ฟ๐ฒ๐๐ถ๐ฒ๐: 6-12 months๐ง๐ผ๐๐ฎ๐น ๐ฎ๐ฝ๐ฝ๐ฟ๐ผ๐๐ฎ๐น ๐๐ถ๐บ๐ฒ: 5-10 years ๐๐ถ๐ผ๐๐ถ๐บ๐ถ๐น๐ฎ๐ฟ๐ The approval timeline for ... Read More