FDA

Estimated Time Frames for Obtaining FDA Authorization

ByPharma Digest December 1, 2023December 1, 2023

𝗕𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝘀 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. 𝗣𝗿𝗲-𝗜𝗡𝗗 𝗱𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁: 1-2 years𝗜𝗡𝗗: 1-2 years𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹𝘀: 3-7 years𝗕𝗟𝗔 𝘀𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻: 6 months𝗙𝗗𝗔 𝗿𝗲𝘃𝗶𝗲𝘄: 6-12 months𝗧𝗼𝘁𝗮𝗹 𝗮𝗽𝗽𝗿𝗼𝘃𝗮𝗹 𝘁𝗶𝗺𝗲: 5-10 years 𝗕𝗶𝗼𝘀𝗶𝗺𝗶𝗹𝗮𝗿𝘀 The approval timeline for a biosimilar is typically shorter…

FDA

Types of FDA Applications for Drugs and Biologics

ByPharma Digest November 27, 2023November 27, 2023

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:…

FDA | ICH

Difference Between ICH and USFDA Guidelines

ByPharma Digest November 20, 2023November 20, 2023

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…

FDA | Regulatory Affairs

FDA Requirements For OTC Drugs

ByPharma Digest October 28, 2023October 28, 2023

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…

FDA | Regulatory Affairs

Drug Development and Approval Process | Part III

ByPharma Digest September 13, 2023November 28, 2023

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…

FDA | Regulatory Affairs

Drug Development and Approval Process | Part II

ByPharma Digest September 11, 2023September 13, 2023

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…

FDA | Regulatory Affairs

Drug Development and Approval Process | Part I

ByPharma Digest September 11, 2023September 13, 2023

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

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

ByPharma Digest September 9, 2023September 9, 2023

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

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

ByPharma Digest August 25, 2023August 25, 2023

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,…

Impurities

Highlights of Recent FDA Guidance on Nitrosamine Drug Substance

ByPharma Digest August 13, 2023September 12, 2023

For example, FDA Recommended AI Limits for Certain Hypothetical NDSRIs FDA Recommended AI Limits for Certain NDSRIs Related: APIC Guidance on the Risk Assessment for Presence of N-Nitrosamines in APIs

FDA

Estimated Time Frames for Obtaining FDA Authorization

Types of FDA Applications for Drugs and Biologics

Difference Between ICH and USFDA Guidelines

FDA Requirements For OTC Drugs

Drug Development and Approval Process | Part III

Drug Development and Approval Process | Part II

Drug Development and Approval Process | Part I

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

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

Highlights of Recent FDA Guidance on Nitrosamine Drug Substance

Frequently Asked Questions and Answers on cGMP

Frequently Asked Questions on Data Integrity