Food Drug Administration Fda

Health care professional meeting virtually with another healthcare professional

Pharmacovigilance

Enhancing Animal Health Compliance with Comprehensive Medical Information (MI) and Pharmacovigilance (PV) Services

Comprehensive Animal Health Medical Information (MI) and Pharmacovigilance (PV) support services in the veterinary industry are a must-have for companies who want to ensure the safety, efficacy, and...

Quality & Compliance

Diary of Compliance: A Year in the Life of Ensuring FDA CAPA Standards

Welcome to the Diary of Compliance, where we follow the journey of Allison Audit, the dedicated and detail-oriented Quality Assurance Manager at Acme Pharma. Over the course of a year, Allison takes...

Casually dressed business professionals discussing intensely at a conference table

The Care and Feeding of FDA PMAs: Mastering Premarket Approval

Congratulations, FDA has approved your PMA! Now what? Securing a Premarket Approval (PMA) from the FDA is a significant achievement for any medical device manufacturer—a validation of your product's...

Hand writing on clipboard with a pen

Regulatory Sciences

How a Strong Regulatory Strategy Supports Your Product’s Success

One of the big questions pharmaceutical, biotech and medical device companies often ask, is: “When is the optimal time to seek strategic regulatory consulting assistance?”. Traditionally, the need...

Regulatory Sciences

FDA Drug Labeling Requirements & Regulations: What’s in Your Label?

Why Does Pharmaceutical Product Labeling Matter? Do you know what’s in your product’s labeling and what it is saying about your product? More importantly, do you know why that matters? A drug’s label...

Regulatory Sciences

FDA eSTAR Template: Navigating FDA's 510(k) Submission Requirements

Implementing the eSTAR Format The eSTAR template is a positive step for both CDRH and medical device Sponsors; but, as with any new tool, there are challenges to utilizing the template. Sponsors need...

Hand with pen preparing FDA regulatory documents

Regulatory Sciences

Regulatory Chemistry, Manufacturing, and Controls (CMC): What to Expect During Drug Development

The key to successful drug development in the US is directional and focused navigation of FDA’s Investigational New Drug (IND) process. The Chemistry, Manufacturing, and Controls (CMC) section is a...

Regulatory Sciences

FDA Animal Rule: Overview & Impact on Drug Development

What is the Animal Rule? The Animal Rule, a regulation set by the US Food and Drug Administration (FDA), applies to the development and testing of drugs and biological products intended to reduce or...

Low angle of the United States Capitol Building

Regulatory Sciences

The Impact of a US Government Shutdown on the Food and Drug Administration

This article was originally published in September 2023, and has been updated to reflect an upcoming potential government shutdown. As U.S. lawmakers return from the President’s Day holiday, they are...

Hands gesturing around a table with papers and tablet devices showing charts and graphs

Demystifying CAPA Management: Overcoming Challenges in the Fast-Paced World of GMP

This article has been updated since its original publication date. Navigating the complexities of Corrective Action / Preventive Action (CAPA) in the drug and medical device industries often poses a...

Woman typing on a laptop next to a microscope in a medical laboratory.

Illuminating FDA's 2023 BLA Approvals: A Comparative Analysis

The FDA's Biologics License Application (BLA) approvals in 2023 have marked a significant chapter in medical innovation, embodying precision and transformative therapies. A closer examination of the...

Medical professionals working together at a desk

2023: A New Chapter in FDA Drug Approvals - A Resurgence of Innovation

The year 2023 unveiled an eventful chapter in FDA drug approvals, heralding a resurgence of innovation after a brief decline. This period represented not just a numerical rebound but a meaningful...

Programming code on a computer monitor.

FDA’s Updated Software Guidance

The FDA has recently published a number of software related guidance documents, covering topics such as off-the-shelf software, cybersecurity, closed-loop-control, and predetermined change control...

Navigating FDA User Fee Updates for Fiscal Year 2023

As the U.S. Government begins its fiscal year on October 1, it signifies the annual revisions in FDA User Fees, which have an impact on applications and facilities associated with Prescription Drugs...

Couple reading medication guide together.

FDA Proposes New, Easy-to-Read Medication Guide for Patients

The US Food and Drug Administration (FDA) has proposed a new, easy-to-read medication guide for patients known as the Patient Medication Information (PMI)1. The new medical guide will be required for...

Lab technician injecting syringe into a test tube

FDA's Concern over Diethylene Glycol (DEG) and Ethylene Glycol (EG) Contamination

Recent contamination of several drug products in India resulting in fatalities have prompted a new FDA guidance entitled "Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch...

Prev 1 2 3 4 5