FDA
Anatomy of an FDA Inspection | Part 2 of 2
Winning the Inspection Game – The Habits of Inspection-Ready Companies LIVE THE CULTURE: The entire organization, from top management to line operators, knows that quality isn’t a department—it’s a mindset. It’s part of the air you breathe, the decisions you make. Follow SOPs consistently, encourage employees to report and fix ... Read More
Anatomy of an FDA Inspection | Part 1 of 2
Inspections are how the FDA checks that what’s promised is real: FDA inspections can occur for various reasons – a routine schedule, a follow-up to a prior issue, a pre-approval for a new product, or “for-cause” in response to a specific problem. What Happens During an FDA Inspection? (And What ... Read More
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 “Conducting Clinical Trials with Decentralized Elements.” 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. 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
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. 𝗔𝗱𝗲𝗾𝘂𝗮𝘁𝗲 𝗮𝗻𝗱 𝗪𝗲𝗹𝗹-𝗖𝗼𝗻𝘁𝗿𝗼𝗹𝗹𝗲𝗱 𝗦𝘁𝘂𝗱𝗶𝗲𝘀: 𝗧𝗵𝗲 ... 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