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Newsletter Archive 2024

Newsletter, January 4, 2024

FDA Released 21 New Guidance Documents in the Last 15 Days of 2023

Compounding Pharmacies Fight the Stigma of Unapproved Drug Manufacturing

Newsletter, January 11, 2024

FDA Releases Several MoCRA Support Tools

FDA Creates a Tool to Make it Easy to Find GMP Guidelines

Newsletter, January 18, 2024

FDA Lists Major Compliance Findings From Its Drug Audits in 2023

Using ChatGPT to Write Informed Consent for Clinical Practice and Clinical Trials

Newsletter, January 25, 2024

What Does The Box Warning on Approved CAR-Ts Mean for New CAR-Ts?

What Does FDA’s Reorganized Audit Office Means to You?

Newsletter, February 1, 2024

FDA Unveils the Final Rule for Medical Device GMP Requirements

FDA Unveils Clear Guidelines for Demographic Data in Applications

Newsletter, February 8, 2024

Is the FDA Going to Increase On-Site Inspections of Foreign GMP Manufacturers?

FDA Expectations for QbD for Clinical Trials

Newsletter, February 15, 2024

Charging Patients for Participating in a Clinical Trial? FDA Clarifies Conditions

FDA Updates Guidance for Data Monitoring Committees

Newsletter, February 22, 2024

Getting Non-Clinical Tests For Devices in India and China? FDA Warning

FDA-Acceptable AI-Driven Clinical Summaries

Newsletter, February 29, 2024

In-Person FDA Meetings

Smart Watches to Measure Blood Glucose? “NO” FDA

Newsletter, March 7, 2024

Informed Consent Simplified

Research in Monkeys Depends on Monkey Business for the Supply of Animals

Newsletter, March 14, 2024

FDA’s Inspection Of An Academic Lab Used in Commercial Research

FDA Updates Cybersecurity Requirements for Medical Devices

Newsletter, March 21, 2024

FDA Dings Medical Device Trial for Lack of IRB Review and Monitoring

The Impact of the US Law Banning WuXi on its US Customers

Newsletter, March 28, 2024

GAO Evaluated Limitations of the FDA’s GCP Audits

How Good Are New Drugs Compared to Previous Treatments?

Newsletter, April 4, 2024

How Does FDA Ensure Food Does Not Contain Harmful Chemicals?

Artificial Intelligence to Replace Physicians: Are We There Yet?

Newsletter, April 11, 2024

Can FDA Approval Be Reversed by Public Opinion?

FDA Registration of New Dietary Ingredients Detailed

Newsletter, April 18, 2024

FDA’s New Center for Clinical Trial Innovation: Would it Help the Sponsors?

Lily’s Legal Woes Due to Compounded Copies of Its Blockbuster Drug

Newsletter, April 25, 2024

Devices Pretending to be Medical Devices on Amazon, and FDA is Helpless.

FDA Releases the Status of Post-Market Studies

Newsletter, May 2, 2024

LDTs No More: FDA Flexes its Muscles to Change the 30-Year Precedence

FDA Suggests Selected Safety Data Collection But Sponsors May Find It Hard

Newsletter, May 9, 2024

When a 500-Patient Study for $36M is a Bargain: True Cost of a Clinical Trial

Marketing Flyers and Scientific Publications for Educating Physicians

Newsletter, May 16, 2024

Does the FDA Really Accept Real World Data?

How ChatGPT Became a Standard to Evaluate LLMs in Healthcare

Newsletter, May 23, 2024

NIH’s New Policy for Licensing Inventions

New Prescription Drug Advertisement Rule Effective This Week

Newsletter, May 30, 2024

First Lawsuit Against FDA’s LDT Rule Wants a New Designation for LDTs

FDA’s Newest Designation - Platform Technology: Is It Worth It?

Newsletter, June 6, 2024

NIH’s Struggles with Diversity in Clinical Trials Too But Less Than Industry

FDA Support For Pragmatic Clinical Trials for Post-Market Studies

Newsletter, June 13, 2024

FDA’s Updated Guidance for AI/ML Medical Devices

FDA’s New Guidance on GCP Inspections

Newsletter, June 20, 2024

FDA’s Updates cGMP Rules for Medical Gases

Ensure GMP Sites Are Ready for FDA Audits to Avoid Delay in ANDA Approval

Newsletter, June 27, 2024

Do We Need an Independent Body to Oversee FDA Decisions?

FDA’s Definition of Unacceptable Behaviour During its Audits

Newsletter, July 11, 2024

How to Deal with Off-Label Information: New FDA Guidance With Old Info

How to Ues Real World Data to Generate New Safety Information for Drugs

Newsletter, July 18, 2024

The Short- and Long-Term Impact of Chevron’s Rejection on the FDA

EU’s Final Rule for AI Devices

Newsletter, July 25, 2024

FDA Updates its SOP for Meetings with Sponsors

Another FDA Guidance on Real World Data

Newsletter, August 1, 2024

The FDA Would Like to See Lifecycle Management for SaMD products

FDA Increases AI, ML, and NLP Tools for Surveillance

Newsletter, August 8, 2024

What is FDA Acceptable Real World Evidence?

Health Equity for Medical Devices: FDA Discussion

Newsletter, August 15, 2024

Trends from FDA-Approved AI/ML Devices

CMS Reimbursement for Breakthrough Medical Devices

Newsletter, August 22, 2024

How the FDA Deals With Unapproved Foreign Traditional Medicines in the US?

Is the FDA’s Competent Generics Program Successful?

Newsletter, August 29, 2024

New Way to Submit DeNovo Medical Device Requests

New Media for Product User Manuals

Newsletter, September 5, 2024

Taxation and Clinical Trial Participation: The Hidden Obstacles

Streamlining De Novo Submissions Using the eSTAR Template

Newsletter, September 12, 2024

FDA Clarifies the Role of Vets in Dispensing drugs for Pets

How to Doctors View and Use Boxed Warnings on Drug Labels?

Newsletter, September 19, 2024

Has the FDA Stopped Accepting Multinational Clinical Trials for Oncology Drugs?

FDA’s New Guidance on Decentralized Clinical Trials

Newsletter, September 26, 2024

Can We Trust Published Peer-Reviewed Scientific Data?

Why did the FDA Release a Guidance for Conducting Clinical Trials at Clinics?

Newsletter, October 3, 2024

Electronic Systems in Clinical Trials: FDA Guidance

FDA Expands the Functionalities of the CDRH Portal

Newsletter, October 10, 2024

FDA’s Resource Page for LDTs to IVD Conversion

IRB Cited for Non-Compliance

Newsletter, October 17, 2024

Diversity in Medical Device Clinical Trials

Changing Perspectives: 20 Years Later, Cancer Due to Gene Therapy is Acceptable

Newsletter, October 24, 2024

FDA Summarizes Plans to Regulate for AI Devices

Should Minimal Risk Clinical Trials Require A Different Informed Consent?

Newsletter, November 14, 2024

Do Doctors Get in Trouble for Spreading Misinformation

FDA’s Advise on Non-Clinical Studies with Oligonucleotide Products

Newsletter, November 21, 2024

FDA’s Comprehensive Advice for Cell and Gene Therapy Product Development

GAO Report Highlights Keys Issues with FDA Audits

Newsletter, December 5, 2024

FDA’s Latest Guidance for AI/ML Devices Adds a New Requirement

Best Practices for Communicating for FDA

Newsletter, December 12, 2024

Expedited Withdrawal of Drugs Approved via the Accelerated Approval Pathway

FDA Registration of Cosmetic Products: Details Available

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