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Newsletter Archive 2023

Newsletter, January 5, 2023

Five Things That Changed Forever at FDA in 2022

FDA’s First Warning Letter of the Year Highlights the Impossibility of Regulating Online Pharmacies

Newsletter, January 12, 2023

FDA Brass Seems to Suggest US-Only Clinical Trials: Is it Practical or Fair?

Can Paying More to Participants Increase Diversity in Clinical Trials?

Newsletter, January 19, 2023

FDA Updates the Clinical Protocol Template

FTC: Dietary Supplements Need Clinical Trials to Support Health Claims

Newsletter, January 26, 2023

FDA Guidance on Clinical Trials with Cannabis: Same Info, Repackaged?

FDA Requirement for Clinical Trial Diversity Action Plans: Are They Useful?

Newsletter, February 2, 2023

“Work From Home” No More: FDA Staff Returns to the Office This Month

FDA Audit Trends, 2023

Newsletter, February 9, 2023

FDA Remembers All Submissions: New Jersey Clinic Learned this Lesson

FDA Lists Four Expectations From Oncology Drug Developers

Newsletter, February 16, 2023

About Half of the New Drugs Approved by FDA Are Not So By Other Countries

FDA’s Guidance on Neonatal Product Testing Highlights Their Impossibility

Newsletter, February 23, 2023

GAO Recommends That FDA Conduct More Robust Audit of IRBs

There is a Lack of Competition for API Manufacturers for Generic Drugs

Newsletter, March 2, 2023

FDA is Out of Touch With Patients’ Needs: A Former HHS Employee

When Your Vendor Screws Up: Pfizer and Care Access for Lyme Trial

Newsletter, March 9, 2023

FDA Raises Several Considerations for Use of AI in Drug Manufacturing

ChatGPT For Drug Development?

Newsletter, March 16, 2023

Survey Points to Challenges and Promise of Expanded Access Treatment

FDA Updates the Guidance for Electronic Records in Clinical Trials

Newsletter, March 23, 2023

FDA updates the Medical Foods Guidance

Animal Drug Approval Based Only on Published Literature is Challenging

Newsletter, March 30, 2023

FDA “New” Policy For Medical Devices with Cybersecurity Issues

Why Do We Still Need Primate Toxicity Studies?

Newsletter, April 6, 2023

Disclose Possibility of Early Termination in Informed Consent: IRB

Trial Does Not Meet the Primary Endpoint? No Worries, FDA Still Might Approve

Newsletter, April 13, 2023

FDA Finalizes Risk-Based Monitoring Guidance with Practical Advice

Digital Health Company’s Bankruptcy Highlights the Challenges of DM Products

Newsletter, April 20, 2023

Why is FDA Quiet About the Off-Label Promotion of Ozempic? Ozempic Vs Viagra

FDA’s Warning Letter Highlights Need for Pre-Approval of Device Modifications

Newsletter, April 27, 2023

FDA Clarifies Electronic Submission of Veterinary Product Applications

EMA Describes Considerations for Single-Arm Studies for Oncology Drugs

Newsletter, May 4, 2023

FDA Advises When to Do or Not Do Decentralized Clinical Trials

NIH-Funded Animal Research Without Ethical Compliance in Columbia

Newsletter, May 11, 2023

COVID Emergency Officially Ends Today But Not EUAs: FDA

FDA Discusses Regulatory Concerns for Use of AI in Drug Development

Newsletter, May 18, 2023

Accelerated Approvals Benefit Companies Over Patients: Bloomberg

Clinical Trial Recruitment is Not Easy: CVS Learns the Hard Way

Newsletter, May 25, 2023

FDA Provides Detailed Guidance on Developing Drugs for Children

Orphan Drugs Are the Most Expensive Drugs In the US Market

Newsletter, June 1, 2023

FDA Returns to In-Person Meetings Starting 12 June

FDA to Require New Patient-Friendly Medication Guides For all Drugs

Newsletter, June 8, 2023

FDA Puts Its Weight Behind Virtual Clinical Trials

FDA Definition of Generally Accepted Scientific Knowledge: Will It Reduce Animal Studies?

Newsletter, June 15, 2023

Can Observational Studies Be Used For Supporting New Treatments?

Should ChatGPT Be An Author on Scientific Papers Written With Its Help?

Newsletter, June 22, 2023

FDA Lists the Most Common GMP Deficiencies Last Year

Race-Based Disease Scores: Good for One, Not For The Other

Newsletter, June 29, 2023

FDA Clarifies Rules for Compounding Pharmacies to Plug a Loophole

Newsletter, July 6, 2023

Off-Label Marketing of Artificial Intelligence Based Software Devices!

How Profitable Are the Rare Pediatric Disease Priority Review Vouchers?

Newsletter, July 13, 2023

Trends in FDA Approval of Breakthrough Devices

FDA Advise on Risk Assessment for Manufacturing Changes for HCT Products

Newsletter, July 27, 2023

WHO’s Clinical Trial Guidance: Same Intent as FDA, With a Twist

FDA Creates a Certification for Foreign Food Suppliers: VQIP

Newsletter, August 3, 2023

Billions Wasted on Futile Onco Drug Development Indicates a Disturbing Trend

When Physicians Recruit Their Own Patients in Clinical Trials…

Newsletter, August 10, 2023

Did NIH Waste Almost a Billion Dollars Over 2.5 Years for an Observational Study?

FDA Registration of Cosmetic Manufacturing Facilities

Newsletter, August 17, 2023

FDA’s New Post-Market Diversity Expectations

FDA Requirements for Using Off-The-Shelf Software in New Medical Devices

Newsletter, August 24, 2023

Pharma Connections in Patient Advocacy Leadership Raises Conflict of Interest Concerns

Should the FDA Increase Dietary Supplement Review

Newsletter, August 31, 2023

FDA Releases Expectations for Using RWE in Support of New Drug Approvals

What You Should Know About the $1 Billion Taxpayer-Funded Covid Trial

Newsletter, September 7, 2023

FDA’s Latest Advice for Strategic Considerations for 510K Applications

FDA Funding for Orphan Drug Clinical Trials

Newsletter, September 14, 2023

The Covid Boosters in the Post-Pandemic Age: Would Covid Be the New Flu?

FDA’s Clarifies its Expectations from IRB Review of Compassionate Use

Newsletter, September 21, 2023

Market Approval Based on a Single Clinical Trial is Possible, But… : FDA

FDA’s Rejects AdCom Recommendation For Approval of Nasal Epinephrine Spray

Newsletter, September 28, 2023

FDA’s Clarifies Meeting Types and Other Details in a New Guidance on Meetings

FDA’s Cybersecurity Requirements for Medical Devices

Newsletter, October 5, 2023

FDA’s Again Tries to Regulate LDTs: This Time It Will Work, Unless….

No More Paper 510k Submissions to the FDA

Newsletter, October 12, 2023

Did Elon Musk Get a Pass from FDA For His High-Risk Device Trial?

Did Pfizer Discontinue 3500 Patients on a Clinical Trial in Error?

Newsletter, October 19, 2023

FDA Warning Letter to an Online Illegal Ozempic Seller

Can the FDA Direct You to Hire a Consultant?

Newsletter, October 26, 2023

FDA’s New Guidance on Off-Label Information Sharing

FDA Warns Against Directed Blood Donations

Newsletter, November 2, 2023

How Does The Executive Order for AI Affect Digital Health Products?

FDA Acceptance Of The Data from Traditional Chinese Medicine for Heart Health

Newsletter, November 9, 2023

One Manufacturer Linked to 26 Product Recalls

FDA Clarifies the Process to Appeal Rejection of Export Certificate Request

Newsletter, November 16, 2023

FDA Lists the Reasons for Denial of BTD Requests

ChatGPT = “Weapon of Mass Disinformation” for Healthcare Information

Newsletter, November 30, 2023

CAR-T Therapies Cause Cancer? FDA Investigates Multiple Reports of Link

FDA Set to Reclassify Several Wound Dressings to Class III Medical Devices

Newsletter, December 7, 2023

All Applicable Clinical Trials Are Already Compliant with Clinicaltrials.gov: FDA

Electronic Submission of PMA to the FDA

Newsletter, December 14, 2023

The Year of ChatGPT: Its Effects on Healthcare and FDA Regulations

Proposed LDT Rule Is The Biggest Impact Event of 2023 in FDA Regulatory Space

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