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Newsletter Archive 2021

Newsletter, January 7, 2021

FDA Raise Important Confidentiality Warning in a New Guidance Document

FDA Issues Year-End Warning Letters to CBD Product Manufacturers, Again

Newsletter, January 14, 2021

Global Regulatory Dilemma Due to the Less Effective Chinese Vaccine

Impact of Last Minute Rules for FDA and HHS by Trump Administration

Newsletter, January 21, 2021

New Administration = New FDA? Not So much

Oncology and Regenerative Medicine Products, and the Biden Administration

Newsletter, January 28, 2021

Fate of Other Covid Vaccines? Where Regulations and Healthcare Collide

Could Social Media Have Prevented the Pandemic? A Reports Says Possibly.

Newsletter, February 4, 2021

FDA’s Between a Rock and a Hard Place for its GMP Inspections

Stop Asking the FDA for Covid Vaccine Supply

Newsletter, February 11, 2021

Janet Woodcock, Tom Brady and Joe Biden: Leadership in 2021

New EU Rule for Human Rights and Environment Abuse in Pharma Supply Chain

Newsletter, February 18, 2021

FDA Points at the Disconnect in What it Tells Companies and What They Disclose

Plavix Case: Deceptive Marketing or Regulatory Non-Compliance

Newsletter, February 25, 2021

Doubting the Placebo in a Placebo-Controlled Study

Cancer Clinical Trials are The Worst Victim Of the Pandemic

Newsletter, March 4, 2021

Too Many Poorly Designed Trials Led to the Lag in Covid Therapeutics: FDA

FDA “Requests” Fraudsters to Stop Making Fake Certificates

Newsletter, March 11, 2021

The Pandemic is Coming to an End, and so are the EUAs.

What is the Future of Covid Vaccines?

Newsletter, March 18, 2021

Lab Supplies Still in Acute Shortage Due to the Pandemic

Do We Really Need FDA’s Pre-Approval Inspections? FDA’s Own Data Say, No.

Newsletter, March 25, 2021

More Regulation is Better for Certain Medical Devices: Industry Tells FDA

FDA’s Tango With the EUAs Exposed an Agency Disconnected from the Real World

Newsletter, April 1, 2021

Do FDA’s Procedures Make it Easier to Cover-up Negative Audit Findings?

FDA’s Internal Processes for Handling Whistleblower Complaints Unmasked

Newsletter, April 8, 2021

Are FDA’s In-Person Meetings Coming Back in the Fall?

How Many Covid Vaccines Do We Need? Fate of Tier 2 Vaccines Seems Grim. 

Newsletter, April 15, 2021

FDA’s Guidance for Remote Audits: Good Intentions, Bad Perceptions

Its Time To Restart Clinical Trials in the US

Newsletter, April 22, 2021

Emergent’s FDA Audit Indicates Poor Vendor Validation by J & J

FDA To Limit Interstate Distribution of Compounded Drugs

Newsletter, April 29, 2021

FDA Starts Enforcing Clinicaltrial.gov Law

FDA to Stem Cell Clinics: File an IND by June 1, or Close Business

Newsletter, May 6, 2021

FDA’s Auditing Resources Are Mostly Spent for Food Facilities, Not Drugs.

How Much to Pay the Patients to Participate in Clinical Trials in the Pandemic

Newsletter, May 13, 2021

“Why EUA, Why Not Approval?” EUAs Fuel Vaccine Hesitancy

You Can Go to Jail For Lying to the FDA (Just in Case, You Did Not Already Know)

Newsletter, May 20, 2021

FDA’s Four Possible Outcomes for No-PAIs Provide Strategic Openings

Covid EUA Holders: Are You Ready For Life After the Pandemic?

Newsletter, May 27, 2021

How Did South Korea Dealt Better With the Pandemic Than the US? Testing

Compliance and Data Integrity Issues with Remote Clinical Trials

Newsletter, June 3, 2021

Is FDA Turning Into a Virtual Organization For Good? It Seems Like It

FDA May Be Considering Ending In-Person Meetings With Sponsors

Newsletter, June 10, 2021

FDA Finally Announces it is Clamping Down on Illegal Stem Cell Clinics

Biogen’s Accelerated Approval for its Alzheimer’s Drug: Controversial but Routine

Newsletter, June 17, 2021

The Biogen Decision Raises a Question: Do We Need FDA Advisory Committees?

“It's All In The Name”: How Titles of Publications Deceive Media.

Newsletter, June 24, 2021

Second Tier Covid Vaccines Struggle: With Good or Bad Results

Fraudulent Academic Research Sinks Company; is it another Theranos?

Newsletter, July 1, 2021

Has FDA Been Corrupted? Tough Questions, Touchy Answers

PROs Have a Bigger Impact on FDA Decisions When Used as Primary Endpoints

Newsletter, July 15, 2021

FDA’s Aduhelm Decision are Permanent, Aduhlem Will Not Be an Exception

FDA Cannot Regulate Off-Label Use by Physicians: Decisive Court Decision

Newsletter, July 22, 2021

FDA’s Decision-Making Process is Immune to Buyer’s Remorse

FDA Would Like Inclusion of Pregnant Women in Clinical Research: Easier Said Than Done

Newsletter, July 29, 2021

FDA’s First Interchangeable Biosimilar: Floodgate for Others?

Is FDA Taking Too Long to Approve the Covid Vaccines?

Newsletter, August 5, 2021

Is FDA’s Accelerated Approval Pathway in Danger of Being Scrapped?

Was FDA Short-Staffed to Handle the Pandemic?

Newsletter, August 12, 2021

Good Quality Real World Evidence is Hard to Come by

Vaccine Misinformation Highlights the Limits of FDA’s Powers

Newsletter, August 19, 2021

The Pandemic Changed Clinical Trials for Good.

Is CBD a Drug or a Supplement? FDA Confuses Again.

Newsletter, August 26, 2021

Will Vaccine Approval Spur Off-Label Vaccination of Young Children?

Accelerate Approval Pathway Does Not Need Reform, But Enforcement and Education

Newsletter, September 2, 2021

FDA: No Need to Re-Monitor Remote Clinical Trials

FDA Start Online 510K-Review Tracker

Newsletter, September 9, 2021

Is It a Drug, Food, or a Medical Food? FDA’s Clarifies Regulatory Semantics

FDA Describes the Process to Develop New Antimicrobial Agents for Food

Newsletter, September 16, 2021

ALS Drug Developer Cashes In on FDA’s Precedence in Alzheimer’s Disease

Biodistribution Studies for Genetic Therapy Products Explained by FDA

Newsletter, September 23, 2021

FDA’s Publication Highlights How to Use/Not Use Precedent Information

Paying Participants Helps with Recruitment for Low-Risk but Not The High-Risk Clinical Trials

Newsletter, September 30, 2021

FDA’s Guidance Describes the Subjectiveness of Benefit-Risk Assessments

Fully Electronic 510k Applications are Coming Soon

Newsletter, October 7, 2021

FDA’s Final Rule for De Novo Classification: Mostly Unchanged Process

FDA’s Tip on Communicating Cybersecurity Issues to Patients: Keep it Simple

Newsletter, October 14, 2021

FDA Eases Compounding Rules for Hospitals: Ever So Slightly but Significantly

ICH Releases Guidance on QbD Approach for Clinical Development Plans

Newsletter, October 21, 2021

Real World Data for Animal Drugs, Too: New FDA Guidance Provides Tips

Are the Digital Medicine Products Moving Too Fast?

Newsletter, October 28, 2021

Covid Vaccines Stole the Limelight from Therapies, it Seems.

10 Principles for Machine Learning or AI Medical Devices from FDA

Newsletter, November 4, 2021

Did Biogen Bribe Doctors or Play it Fairly?

Who’s Responsible for Food Safety: FDA, CDC or USDA?

Newsletter, November 11, 2021

FDA May Soon Require Dose Findings Studies for Oncology Product Approval

RWE Shows that Short-Course Antibiotic Treatment is Better and Safer

Newsletter, November 18, 2021

FDA’s EUA for Covid LDTs Has Minimal Impact on Most LDTs

The Revolving Door Turns a Full 360 degrees with Califf: Why Should We Care?

Newsletter, December 2, 2021

If You Ever Wanted to File a FOI Request with FDA: Forget it.

Did the EUA for Covid Tests, Kill the 510k for them?

Newsletter, December 9, 2021

Clinicaltrial.gov Website Gets a Facelift

FDA Updates the Clinical Outcome Assessment Compendium

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