FDA

Types of FDA Applications for Drugs and Biologics

Types of FDA Applications for Drugs and Biologics

The Electronic Common Technical Document (eCTD) is the standard, accepted electronic format for the following submission types: An eCTD publishing tool is recommended to automatically create the eCTD sequence folder and file structure. FDA does not recommend specific tool vendors, however, they can be located via internet search. For information on eCTD format, please visit:…

Difference Between ICH and USFDA Guidelines
|

Difference Between ICH and USFDA Guidelines

ICH and USFDA guidelines are two of the most important sets of regulations for the pharmaceutical industry. Both sets of guidelines aim to ensure the safety, efficacy, and quality of pharmaceutical products. However, there are some key differences between the two sets of guidelines in terms of their scope, jurisdiction, development process, and applicability. ICH…

Difference Between 21 CFR Part 11 and EU GMP Annex 11
|

Difference Between 21 CFR Part 11 and EU GMP Annex 11

Navigating the complex waters of Life Sciences regulations? Two standards tower above the rest – 21 CFR Part 11 and EU GMP Annex 11. Here’s why they’re non-negotiable: Foundation of quality and integrity: Both safeguards ensure the highest standards of Quality, product integrity, and safety in the Life Sciences. Compliance isn’t just about checking legal…

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 doctor’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 world for use without medical…

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 of the fact that it…

Drug Development and Approval Process | Part II
|

Drug Development and Approval Process | Part II

FDA Approval: What It Means FDA approval of a drug means that data on the drug’s effects have been reviewed by CDER, and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population. The drug approval process takes place within a structured framework that includes: 1. Analysis…

Drug Development and Approval Process | Part I
|

Drug Development and Approval Process | Part I

Developing New Drugs American consumers benefit from having access to the safest and most advanced pharmaceutical system in the world. The main consumer watchdog in this system is FDA’s Center for Drug Evaluation and Research (CDER). Drug companies seeking to sell a drug in the United States must first test it. The company then sends…

FDA Inspection and Findings on Current Good Manufacturing Practice (CGMP)

FDA Inspection and Findings on Current Good Manufacturing Practice (CGMP)

The FDA conducted an inspection of a manufacturing facility located in the US and found significant violations of Current Good Manufacturing Practice (CGMP) regulations. The violations identified include the following: The FDA requested the following actions in response to the identified violations: Recommendation: The firm should consideration of engaging a qualified consultant to assist in…

FDA Compliance Guide on Pre-approval Inspections (PAI) for Drugs

FDA Compliance Guide on Pre-approval Inspections (PAI) for Drugs

Pre-Approval Inspections (PAIs) are one of several significant milestones with an outsized impact on product approval and market entrance in FDA regulated industries. While organizations that have successfully navigated product development before often ingrain PAI readiness into their processes, companies of all sizes routinely need to devote time and energy to diligent preparation. Very often,…

FDA Findings and Remdies on cGMP Violations

FDA Findings and Remdies on cGMP Violations

The U.S. Food and Drug Administration (FDA) recently inspected a US drug manufacturing facility and identified several significant cGMP violations, resulting in a Warning Letter (#649198). The violations include: Here are five remediation actions that the company should take: Cleaning and Maintenance Procedures: Investigations and Deviations: Production and Process Control Procedures: Contamination Prevention: Independent Assessment:…