Guidelines

Types of FDA Applications for Drugs and Biologics

Types of FDA Applications for Drugs and Biologics

FDA

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 ... Read More
Difference Between ICH and USFDA Guidelines

Difference Between ICH and USFDA Guidelines

FDA, ICH

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, ... Read More
Difference Between 21 CFR Part 11 and EU GMP Annex 11

Difference Between 21 CFR Part 11 and EU GMP Annex 11

EMA, FDA

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 ... Read More
How the ICH Quality Guidelines Fit Into the Drug Development Process

How the ICH Quality Guidelines Fit Into the Drug Development Process

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has developed a set of quality guidelines that are crucial for the safety, efficacy, and quality of pharmaceutical products. Here’s how these guidelines fit into the different phases of drug development: Preclinical Development Clinical Development Registration ... 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 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 ... 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
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 ... Read More
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 ... Read More
FDA Inspection and Findings on Current Good Manufacturing Practice (CGMP)

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

FDA

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

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

FDA

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 ... Read More
Good Practices for Research and Development (R&D) Facilities | WHO Guideline

Good Practices for Research and Development (R&D) Facilities | WHO Guideline

WHO

With an ever-increasing awareness of the risks in pharmaceutical production and control and the lifecycle approaches being followed, greater emphasis is being placed on ensuring that the research and development of products are appropriately controlled and documented. Consequently, it is necessary that manufacturers of pharmaceutical products are able to submit ... Read More