Pharma Specialists

FDA

FDA Form 356h | The Basics You Need to Know

FDA Form 356h, officially titled "Application to Market a N…

January 06, 2025

FDA

ANDA Submissions | Amendments to ANDA Under GDUFA

Today, FDA revised the final guidance for industry entitled, “AN…

September 12, 2024

FDA

FDA Form 483 | What You Need to Know

Ever wonder what happens when the FDA finds issues during an ins…

August 27, 2024

FDA

Wholesale Distributor and Dispenser Verification | FDA Guidance for Industry

Wholesale Distributor Verification Requirement for Saleable Retu…

June 08, 2024

FDA

Standard for Uniform Blood and Blood Component Container Labels

FDA is issuing this guidance for immediate implementation in acc…

May 10, 2024

Audit

FDA Quality Audits and Critical Observations

2022 - 2023 USFDA trend says on top 5 observations category as f…

March 16, 2024

ANDA

Amendments and Requests for Final Approval to Tentatively Approved ANDAs | FDA Guidance for Industry

This guidance is intended to assist applicants in preparing and …

February 10, 2024

Clinical Trials

FDA Audit Checklist for Clinical Trials

FDA inspections for clinical trials are generally conducted when…

December 05, 2023

FDA

Relationship Between 21 CFR 820 and ISO 13485

1. Scope: 21 CFR 820: This regulation, also known as the Quality…

October 30, 2023

FDA

Quality Considerations for Topical Ophthalmic Drug Products | FDA Guidance for Industry

This guidance discusses certain quality considerations for ophth…

October 23, 2023

Clinical Trials

Clinical Drug Interaction Studies with Combined Oral Contraceptives

This guidance is intended to help sponsors of investigational ne…

June 15, 2023

AI

Artificial Intelligence and Machine Learning in Drug Development and Manufacturing

Recently FDA releases two discussion papers to spur conversation…

May 12, 2023

FDA

Types of FDA Regulatory Submissions

As pharmaceutical professionals, we know that the US FDA regulat…

March 14, 2023

Dissolution

Dissolution Specification Setting Procedure as per FDA Guidance

In vitro dissolution specifications are established to ensure ba…

February 10, 2023

FDA

How to Respond to an FDA 483 Observations?

GMP deficiencies are sometimes found during FDA inspections. I…

January 25, 2023

FDA

Most Common FDA 483 Observations

1. The responsibilities and procedures applicable to the quali…

January 21, 2023

FDA

FDA Inspection Database

The Food and Drug Administration (FDA) conducts inspections and …

January 19, 2023

FDA

FDA Quality Metrics for Drug Manufacturing

For pharmaceutical manufacturing, quality metrics are an objecti…

January 01, 2023

FDA

Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe | FDA New Guidance

This guidance is intended to assist applicants of abbreviated ne…

December 16, 2022

FDA

FDA Pre-Approval Inspection (PAI)

A pre-approval inspection (PAI) is performed to contribute to …

November 14, 2022