FDA Continues to Cite OTC Drugmakers for CGMP Violations

A Guide to FDA's New Inspection Protocol Project (NIPP) for Sterile Manufacturing Sites

FDA’s Crackdown on OTC Manufacturers: A Guide to CGMP Compliance

FDA Medical Device Inspections in 2019: Inside 2 Recent Draft Guidances

A Guide to FDA's 'Risk-Based' Site Selection Model for CGMP Surveillance Inspections

FDA Increases 'Risk-Based' Drug Manufacturing Inspections & Strengthens Genotoxic Impurity Testing

5 Steps to Creating an Effective Life Science Validation Team

Inside FDA's Final Guidance on Device Manufacturing Site Changes

8 Problems That Can Lead to Medical Device Complaint Backlogs

CAPA Compliance: 4 Problems That Can Threaten Your Process

An Informed Guide to Human Error in CAPA

Medical Device Document Control: 4 Common Issues to Avoid

What The FDA Expects From Your CAPA Process

FDA to Add Cybersecurity to RTA Checklists & Other Criteria For Premarket Review

FDA Announces Increased Risk-Based Oversight for 503A & 503B Compounding Facilities

The Problem with 8D for CAPA Under FDA and ISO Regulations

Data Integrity Remediation: A Quick-Guide to Investigating & Resolving Root Cause

4 Ways Regulatory Compliance & QA Consultants Offer Unique Value & Cost-Effectiveness

How to Determine When CAPA is Appropriate

EUDAMED Nomenclature Requirements: Inside the First EU MDR and IVDR Guidance

5 Key Questions to Ask After Receiving an FDA Warning Letter

EU MDR Compliance & Transition: A Strategy for Implementation

The First Step in Transitioning to EU-MDR Compliance

A Quick Guide to Clinical Evaluation Under EU-MDR

FDA Final Rule: Foreign Medical Device Trials Must Conform to GCP

New Report Analyzes Recent Spike in CDER Warning Letters

Conducting Data Integrity Audits: A Quick Guide

MDR vs. MDD: 13 Key Changes

Is Medical Device Risk Analysis Required by the FDA?

[Free Webinar] The Complete Guide to EU-MDR Transition

Foreign FDA Inspections: A Guide to FDA's Pre-Inspection Procedures

Preparing for FDA's Proposed CGMP Regulations for Compounding Pharmacies

FDA Warning Letter & Enforcement Trends of 2017: A Year in Review

Compounding Pharmacies and CGMP: A Primer

Preventing FDA Refuse-to-File Decisions for NDAs, ANDAs, and BLAs: A Quick Guide

Assessing the Applicability and Necessity of CGMP to Drug Compounding

[Webinar Snippet] Key QMS Components for Compounding Pharmacy CGMP Compliance

4 Ways Data Integrity is Being Improved in Clinical Research

5 Items on FDA's 2018 Regulatory Agenda

Quality System Centralization vs. Decentralization: The Pros & Cons

FDA Makes Changes to Priority ANDA Draft Guidance

3 Key Areas to Assess When Integrating an Incoming Quality System

[Free Webinar] The Importance of CGMP to the Safety of Compounded Drugs

FDA Will Recognize GMP Inspections from 8 EU Countries

[Free White Paper] Harmonizing Disparate Quality Systems

3 Clarifications Made in FDA's 510(k) Submission Final Guidances

HHS Office of Human Research Protection Delays Implementation Deadline for Changes in Common Rule

503A vs. 503B: A Quick-Guide to Compounding Pharmacy Designations & Regulations

Canada Still On-Track for 2019 MDSAP Deadline

Combination Product Compliance: 5 Key Factors to Consider

[Free Recorded Webinar] Harmonizing Disparate Quality Systems

For the First Time, The FDA Group Appears on Vault’s 2018 Rankings for Best Consulting Firms for Work/Life Balance

For the Third Time in a Row, The FDA Group Appears on Inc. 5000 List of America’s Fastest-Growing Private Companies

Medical Device Submission & Filing Fees Are About to Rise Significantly

FDA Warning Letters in 2017: A Mid-Year Trend Report

A Basic Guide to Writing Effective Standard Operating Procedures (SOPs)

4 Ways ICH E6 (R2) 2016 Impacts Good Clinical Practice (GCP)

Audit Trail Requirements in Electronic GxP Systems: A Quick Guide

Ensuring MDSAP Readiness Through a Preparatory Audit

A Quick Guide to MDSAP's New Nonconformity Grading System

The FDA Group's Brie Stoianoff & Husband Kevin Byrne Discuss Their Mission to End MS on Portland Today

3 Ways to Prepare for the MDSAP Internally

[Free Webinar] Preparing for the Medical Device Single Audit Program

The FDA Group's Larry Stevens to Baltimore Sun: The Regulatory Path to Warning Labels for Acid Reflux Drugs

CSV & Remediation: 6 Components of a Successful Program

Using Quality Risk Management to Cultivate a Culture of Quality

GxP Electronic Record Metadata: Mitigating Regulatory Risks

5 Steps to Ensuring CAPA Compliance

An Ethical Framework for Enterprise-Wide Data Integrity

6 Ways to Ensure Data Integrity in FDA-Regulated Industries

Audit Trail Checklist: 8 Questions to Ask When Configuring GMP QC Laboratory Audit Trails

[Free Recorded Webinar] Ensuring Enterprise-Wide Data Integrity in FDA-Regulated Industries

The Anatomy of an MDSAP Audit

FDA Warning Letters in Early 2017 Highlight Need for GMP Audits at Foreign Sites

GMP vs. GLP in Laboratory Testing & Validation

ISO 13485:2016 & MDSAP: How to Prepare Your QMS Now

6 Ingredients of an Effective Internal Audit Program

The Data Integrity Triad: A Framework for FDA-Regulated Manufacturers

6 Key Medical Device Provisions in the 21st Century Cures Act

FDA Issues Final Guidance Covering CGMP Requirements for Combination Products

Inadequate CAPA Tops List of Compliance Problems for Medical Device Companies in 2016

3 Important Changes in FDA's Final Guidance for Postmarket Medical Device Cybersecurity

How the 21st Century Cures Act Will Accelerate Medical Device Approvals

A 5-Step Guide to Qualifying FDA-Regulated Suppliers

A Risk-Based Approach to Managing Supplier Quality

A Quick Guide to FDA's Expectations for Supplier Quality

FDA Guidance Clarifies Quality Agreement Expectations for Drugmakers

NH-ISAC, MDISS & FDA Announce New Medical Device Cybersecurity Initiatives

Qualifying Suppliers & Managing Quality in FDA-Regulated Industries [Webinar]

How to Prepare for an FDA Inspection: 6 Quick Tips

Does My Modified Medical Device Require a New 510(k)?

Risk Management & Medical Devices: 4 Common Problems to Avoid

Medical Device Cybersecurity: New FDA Recommendations for Manufacturers

Longer Orphan Drug Review Times: Advice for Manufacturers

Press Release: The FDA Group Appears on Inc. 500 List of America’s Fastest-Growing Private Companies for the Second Year in a Row

Press Release: The FDA Group Hires Industry Expert Brie Stoianoff as Director of Quality & Service Assurance

Adopting FDA’s Benefit-Risk Approach to Medical Device Compliance & Enforcement Decisions

6 Supplier Quality Mistakes FDA-Regulated Companies Should Avoid

6 Reasons to Get Expert Help When Handling Warning Letters & FDA 483

A 5-Step Guide to FDA Warning Letter Recovery

5 Tips for Writing an Effective FDA 483 Response

CEO One on One with The FDA Group President, Nick Capman

9 Top FDA 483 and Warning Letter Problems for Device Companies in 2015

Press Release: The FDA Group Ranks #3 on Boston Business Journal's "FAST50" 2016

8 Key Points from The FDA’s Draft Guidance on Data Integrity and CGMP Compliance

The FDA’s Final Quality Metrics Guidance: 3 Smart Ways to Prepare Now

3 Key Elements of a Successful CAPA System

3 FDA Warning Letter Trends for 2016

The Quick Guide to FDA Part 11 Compliance

5 Ways to Identify the Root Causes of Regulatory Compliance Issues

5 Common Mistakes to Avoid in Your FDA 483 Response

6 Mistakes to Avoid When Submitting a 510(k) to the FDA

FDA Presents Guidance Agenda for 2016

How to Prepare Class II Devices for Compliance with The FDA’s UDI Mandate

5 Items to Stock in Your FDA Inspection War Room

5 Indirect Costs of an FDA Warning Letter

4 Things the FDA Looks for in Quality Metrics

Meaningful Use Program Suspended: What You Need to Know

Why Medical Device Manufacturers Should Focus on Post-Market Data in 2016

3 Things to Expect from the CDRH in 2016 and 2017

How a New FDA Program Helps Pharmaceuticals Implement Emerging Technology

10 Key Elements of an FDA 483 Response

FDA Group’s Larry Stevens Finds Major Issues With Sen. Cruz’s FDA Overhaul Proposal

What Happens During an FDA Inspection?

The 3 Ingredients of an FDA-Compliant Tweet

3 Parts of a Comprehensive GCP Quality Audit

How to Choose the Right Expedited FDA Approval Program

The FDA Finalizes Proposal to Implement Regulations on Lab-Developed Tests

The FDA Group President Nick Capman Interviewed at Vistage Executive Summit 2015

Laboratory Developed Tests: Issues and Anticipated Regulations

The Latest on the Generic Drug User Fee Amendment

FDA Postapproval Issues: An Overview

New FDA Proposal for Quality Metrics

The FDA's Biosimilar Naming Guidelines

The FDA and Nanotechnology

Personalized Medicine and the FDA

How to Handle Reporting of Adverse Events

5 Steps in Developing Remediation Projects

What Is a De Novo Classification?

Press Release: The FDA Group Ranks No. 294 on the 2015 Inc. 500|5000 List

The Section 513(g) Mechanism Explained

What to Consider When Designing Human Factor Studies

How the Orphan Drug Act Offsets Treatment Development Costs

The Differences Between GCP, GLP and GMP Audits

4 Important Features of Compliance Training Systems

What is an Investigational Device Exemption?

3 Advantages of Working with an FDA Consulting Firm

A Basic Guide to the Medical Device Single Audit Program

What You Should Know About Compounding Pharmacy Laws

What To Do If You're Issued a Form FDA 483

A Basic Guide to Mock FDA Audits

New UDI Regulations: What You Need to Know

New Drug Applications: What You Should Know

Clinical Research and Electronic Informed Consent

What Makes for a Good Validation Master Plan?

The FDA Safety and Innovation Act: The Impact Thus Far

Monitoring of Adverse Drug Events: Guidelines and Requirements

Developing Effective Standard Operating Procedures

A Middle Ground for Mobile Heath?

The 505(b)(2) Application Mechanism Explained

A Basic Guide to the Electronic Common Technical Document

A Basic Guide to Unique Device Identifiers

Part 11 of Title 21 of the Code of Federal Regulations

FDA Quality Control in the News

Packaging Guidelines in 21 Code of Federal Regulations Part 211

The FDA Group Quoted In Article

FDA Regulatory Structure for Medical Devices

3D Printers and the FDA: Part Two

3D Printing and the FDA: Part One

A Brief Overview of ISO9001

The FDA's Registration Process for Medical Devices

The Basics of Pharmacovigilance Audits

Overview of the FDA 510(k) Process for Medical Devices

Device Recalls Versus Device Enhancements

A Brief Guide to Small-Molecule Compounds and FDA Regulations

How to Manage the Risk of Medical Devices

The Guide to Biosimilars: FDA Regulations and Guidelines

4 Steps of the FDA's Premarket Approval Process

Why Quality Assurance is So Important to Pharmaceuticals

The 4 Steps of an Effective Mock FDA Inspection

The FDA’s Policy on Social Media Use Explained

What "Right to Try" Laws Mean for Pharmaceuticals

Reclassification of Transvaginal Mesh: An Update

New Regulations for Lab-developed Tests

The Regulatory Environment in Europe

The Biologics License Application (BLA) Process Explained

New Guidances & Guidelines Regarding Compounding

Section 503B and New Specifications

The Importance of Medical Device Labeling - do not show

An Overview of the FDA’s 510(k) Approval Process

I Received an FDA Warning Letter, Now What?

9 Ways an FDA Compliance Consultant Can Help Your Firm

What to Submit for ANDA Stability Testing

An Overview of the FDA’s Approval Process for Generics

FDA Proposes Expedited Device Approval Process for Unmet Patient Needs

How Safe Are Drugs Made in India?

Recent FDA Opioid Changes Cause Uproar

CenterWatch on The FDA Group

FDA Issues FDASIA Report on Strategy for Risk Based Approach to Health Information Technology