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Newsletter Archive 2025

Newsletter, January 9, 2025

FDA Releases a Record 31 New Guidance Documents in 2 Days: Is It an Anomaly?

New Drug Approvals in 2024: What is the Fine Print?

Newsletter, January 16, 2025

Accelerated Approval Pathway’s New Stricter Requirement

Newsletter, January 23, 2025

Why Investigating Deviation is Critical for GMP Compliance

How to Collect Biopsies in Clinical Trials

Newsletter, January 30, 2025

Does Diversity in Clinical Trials Still Matter to the FDA?

Why is There No Treatment for Long Covid Years After the Pandemic?

Newsletter, February 6, 2025

What Does DeepSeek Teach the Pharma Developers?

Does Your IRB Have These 55 SOPs? FDA Gives a List

Newsletter, February 13, 2025

How Hard is it to Conduct Clinical Trials in the US?

Conducting Trials with Supplements Without an IND Gets a Warning Letter

Newsletter, February 20, 2025

Will FDA’s Political Vulnerability Influence What New Drugs Are Approved?

Should You Delay Your Submissions if Your FDA Review Team Got Fired?

Newsletter, February 27, 2025

Surprise, Social Media Promotion of Medical Testing is Deceptive

Improper Donor Testing at IVF Clinic: FDA Warning Letter

​Newsletter, March 13, 2025

Chasing Profits: The Drug Companies' Ethical Dilemma

Can AI Replace Doctors in Patient Care Conversations?

​Newsletter, March 20, 2025

Developing Treatments for Rare Disease: FDA’s Case Studies

Beyond Government Grants: A Diversified Funding Strategy for Drug Development

​Newsletter, March 27, 2025

Why Randomized Trials Matter: The Case for Controlled Trials

FDA Flags Serious Data Falsification at a Chinese Medical Device Testing Facility

​Newsletter, April 10, 2025

EMA Advice on How to Use Real World Data

LDTs are Back: This Time it May be for Good

Newsletter, April 17, 2025

FDA Signals Reduced Emphasis on Animal Testing For Drug Approvals

Sex-Specific Data in Medical Device Trials: FDA’s Latest Guidance Document

Newsletter, April 24, 2025

Using Historical Controls for FDA Approval of Medical Devices

Why the PDUFA Program is Vital for FDA Drug Approvals—and Patient Lives

Newsletter, May 1, 2025

NIH Joins FDA’s Move Toward Lesser Animal Testing

Clinical Trials Meet Real-World Data

Newsletter, May 8, 2025

Manufacturing Drugs in the US: The Real Challenge

FDA to Increase Unannounced Foreign GMP Inspections

Newsletter, May 15, 2025

HHS and FDA Launch Bold Drive to Cut Regulations

FDA to Use ChatGPT-Like LLMs for Application Reviews

Newsletter, May 22, 2025

HHS and FDA Aim Big Use of Big Data in Medicine: Genius or Wishful Thinking?

The End of Animal Testing? New FDA Rules Aim to Transforming Drug Development

Newsletter, May 29, 2025

Why Many FDA-Approved AI Devices Fall Short in the Clinic.

Single-Arm Studies for Cancer Drug Approvals: FDA Hesitates to Create Precedent

Newsletter, June 5, 2025

ChatGPT Has a Little Sister, Her Name is Elsa, and She Lives at the FDA

FDA Spent 20 Years Chasing LDTs and a Federal Court Pulled the Plug Permanently

Newsletter, June 12, 2025

NIH’s Ambitious AI Strategy: Visionary or Overreach?

When Drug Criticism Slides into Conspiracism

Newsletter, June 19, 2025

FDA’s CNPV Program Aims to Revolutionize Drug Reviews — But Will It Deliver?

Clinical Trial Without IND for a Supplement Gets Warning Letter

Newsletter, June 26, 2025

America’s Science Meltdown—And the Opportunity Rising From the Ashes

New FDA Crackdown on Overseas Cell Trials: Policy or Political Theater?

Newsletter, July 10, 2025

FDA’s 2025 Cybersecurity Guidance: What Every Medical Device Manufacturer Must Know

How to Get FDA Approval for Critical Antibiotics?

Newsletter, July 17, 2025

FDA Ends $800 Exemption—Here’s What Importers Need to Know

The Case Against 2:1 Randomization: Why Equal Allocation Still Wins

Newsletter, July 24, 2025

EHRs Weren’t Built for Science — Here’s How to Fix That

How the FDA and Doctors Can Reassure Patients About AI

Newsletter, July 31, 2025

How Registration Can Rescue Observational Studies from Bias and Hype

FDA’s White Paper Emphasizes that Quality Pays

Newsletter, Aug 14, 2025

Food as Medicine: How Culinary Clinics Are Changing Healthcare

Embryonic Stem Cells and mRNA Vaccines

Newsletter, Aug 21, 2025

New FDA Guidelines Aim to Strengthen Survival Data in Oncology Drug Approvals

Inside the FDA’s Fast-Track Program for Medical Devices

Newsletter, Aug 28, 2025

From Turmeric to Tea: Why Natural Products Deserve a Fairer Conversation  

Daily FAERS Data: The FDA’s Promise of Transparency—But at What Risk?

Newsletter, Sept 4, 2025

New Regulatory Strategy for Ultra-rare Disease Products

Illinois Bans AI Therapy: What It Means for the Future of Mental Health Apps  

Newsletter, Sept 11, 2025

“What Happens When FDA’s Representations May Be False Or Misleading?”: Not Much

Risk-Based, Flexible, Modern: Inside the ICH E6(R3) GCP Guidance

Newsletter, Sept 18, 2025

FDA Guidance Embraces Hybrid Inspection Model for GMP Facilities

Study Highlights Challenges with Externally Controlled Trials

Newsletter, Sept 25, 2025

FDA Two Guidances Try to Bridge Clinical Trials for Cell Therapy Products

Expedited FDA Approval of Stem Cell Therapies

Newsletter, Oct 2, 2025

ICH E20 vs. FDA 2019: Global Adaptive Trial Standards Redefined

Cosmeceuticals and Supplements: The Pseudo-Science Behind the Labels

Newsletter, Oct 9, 2025

FDA’s Domestic Push: PreCheck and the Global Reality of Generic Drugs

Data Integrity in Drug Trials: What the FDA’s GCP Inspection Data Reveals

Newsletter, Oct 16, 2025

Is There Still A Good Scientific Justification for Animal Testing for New Drugs?

Pivoting Through Politics: A Strategic Guide for Vaccine Developers

Newsletter, Oct 23, 2025

Compassionate Use vs. Right to Try: Which Path Saves More Lives?

FDA’s PFDD Guidance: Turning Patient Voices into Regulatory Evidence

Newsletter, Oct 30, 2025

Will AI Terminate Human Medical Writers?

When Comparative Efficacy Studies Aren’t Needed for Biosimilars

Newsletter, Nov 6, 2025

Keep Submitting: The FDA Review Clock is Ticking During the Shutdown

The FDA Refuse to File Checklists: Your Guide to a First-Cycle Approval

Newsletter, Nov 13, 2025

The Hidden Flaw in FDA-Approved AI Medical Devices

Real-World Evidence in EMA Drug Approvals

Newsletter, Nov 20, 2025

FDAMap’s Strategy for Personalized Stem Cell Therapy in the GCC

FDAMap Expands Regenerative Stem Cell Therapy Initiatives in South America

Newsletter, Dec 4, 2025

FDA Encourages Non-Animal Methods in Monoclonal Antibody Safety Testing

New eCopy Rules — What Companies Must Know.

Newsletter, Dec 11, 2025

The FDA Just Rewrote the CAR-T Rulebook – Quietly

Regulatory Considerations for Biosimilar Promotion

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