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Newsletter Archive 2020

Newsletter, January 9, 2020

Faster Approval Rates Show Increased FDA-Industry Collaboration

Healthcare Administrative Costs Are Three Times The Cost of Drugs

Newsletter, January 16, 2020

Is FDA in Trouble: NY Times Thinks So

Google’s Quest for Medical Records Will Lead to New Products From Google

Newsletter, January 23, 2020

No One Cares if You Post or Not Post Results on Clinicaltrials.gov: Reports

When FDA Plays God, Patients and Doctors Need to Step Up

Newsletter, January 30, 2020

FDA’s Interpretation of HCT/Ps is Subject to Legal Review - Federal Judge

Shkreli Keep Giving Valuable Lessons in the Dirty Secrets of the Drug Industry

Newsletter, February 6, 2020

Solutions to Increase Reliability of Clinical Trial Data From Wearable Devices

Why Do Academic Centers Fail At Timely Submitting Results to Clinicaltrials.gov?

Newsletter, February 13, 2020

Buying Patient Opinion at FDA Advisory Committee Meetings is the Norm

Companies Buying Health Data For Developing Products Should Pay Patients

Newsletter, February 20, 2020

FDA Has the Final Say For What Studies Are Needed for Approval

Does FDA Allow Cockroaches and Rat Hair in Chocolate?

Newsletter, February 27, 2020

Peer Reviewed Publications Mostly Lack Raw Data

Government Reports List Ways to Reduce Admin Burden of Electronic Medical Records

Newsletter, March 5, 2020

FDA Counters Coronavirus Based on the Realities of the Connected World

FDA Approval of Generic Daraprim Demonstrates the Slowness of FDA Process

Newsletter, March 12, 2020

FDA Suspends GMP Inspections But All Other Tasks Continue

Academic Research INDs to Follow CTD Format: FDA Guidance

Newsletter, March 19, 2020

FDA Guidance for Trials in Pandemic Hints that Virtual Clinical Trials Are Least Affected

FDA Launches New Nutritional Label Education Campaign

Newsletter, March 26, 2020

Solutions to Increase Reliability of Clinical Trial Data From Wearable Devices

Can You Rescind an Orphan Designation? Lessons from Gilead-FDA

Newsletter, April 2, 2020

Emergency Situation is Not A “Free-For-All” for FDA-Regulated Products

How Long Should It Take to Develop a Treatment for COVID-19?

Newsletter, April 9, 2020

Is FDA Too Slow to Deal With a Pandemic?

FDA Warns Antibody Based COVID-19 Tests Are Not “Approved”

Newsletter, April 16, 2020

Pandemic is Boom Time of Digital Health Companies

How Easy is to Get an IND from FDA for a COVID-19 Drugs?

Newsletter, April 23, 2020

Real World Data for Emergency Use Approval of COVID-19 Therapies

NIH Offers Depressing “Treatment Guidelines for COVID-19” Patients

Newsletter, April 30, 2020

Are There Too Many Clinical Trials for COVID-19 Therapies?

The Negative Outcomes of Pre-EUA: Lessons from COVID Antibody Tests

Newsletter, May 14, 2020

FDA Releases a Checklist of Restaurants Looking to Re-Open

Patient-Funded Clinical Trials Are an Option for Patients

Newsletter, May 21, 2020

Moderna and Gilead Teach the “Value for Speed” in Pharma

Physician’s Perspective in Using Clinical Trials Data in Patient Care

Newsletter, May 28, 2020

Meetings with FDA, As You Have Known, May be History

In the Race for Home-Based Rapid COVID Tests, Antibody Tests Show Promise

Newsletter, June 4, 2020

FDA Released Free Electronic Informed Consent Tool But Will Anyone Use it?

Use of Surrogate Endpoints for FDA Approval is Common in Cancer Drugs

Newsletter, June 11, 2020

Innovio’s Fate Rests on a Contractor: Client-Contractor Relationship 101 

Publication Bias Versus Deficient Peer Review: Chloroquine Data Lessons

Newsletter, June 25, 2020

Gottlieb and McClellan Critique FDA’s Requirements for COVID Clinical Trials

Stem cell clinics should file an IND, Now

Newsletter, July 9, 2020

Too Many COVID Clinical Trials Creating “Traffic Jams”?

What is the Actual Cost of Clinical Trials?

Newsletter, July 16, 2020

Covid Vaccine Will be The “October Surprise” One Way or the Other

FDA to Begin GMP Inspections Next Week, Sort of.

Newsletter, July 23, 2020

Employees in Clinical Trials Boost or Bust the Prospects of a Company?

FDA Extends Stem Cell Enforcement Discretion, With a Heavy Heart

Newsletter, July 30, 2020

The Coronavirus Billionaires: Are the Taxpayers Getting a Fair Deal?

Getting Celebrity Testimonials to Push the Envelope for Promising Products

Newsletter, August 6, 2020

COVID Proves It Does Not Take 10 Years to Develop a New Product

Grandma May Not Use Telemedicine, and that’s OK

Newsletter, August 13, 2020

Most Americans Will Take the Russian Coronavirus Vaccine, if Available Today

Why is There so Little News About Drugs to Treat Covid-19?

Newsletter, August 20, 2020

Violators of Clinicaltrials.gov Requirements Given a Break by FDA

FDA To Continue Remote Audits At Least Through The Rest of the Year

Newsletter, August 27, 2020

FDA Has For Forever Tainted Plasma Treatment for COVID with Bad Politics

HHS Clarifies that FDA Cannot Regulate LDTs

Newsletter, September 3, 2020

Fraud at a Clinical Trial Company in Ohio Highlights Enforcement Challenges

Can You Use Self Experimentation Data for FDA Approval of Products?

Newsletter, September 10, 2020

Can the US Government Force Companies to Release Covid Vaccines Early?

FDA Has Issued No Warning Letters For GMP Non-Compliance Since March

Newsletter, September 17, 2020

“Storage and Shipping Wars” Will Add to the Pain of the Pandemic

Cannabis Manufacturers Should File DMFs To Help Drug Development: FDA

Newsletter, September 24, 2020

Off-Label Promotion by Manufacturers: FDA Modifies Rules for Enforcement

FDA Creates a New Center for Digital Health Products

Newsletter, October 1, 2020

FDA Tightens ANDA Review and Rejection Timelines

FDA’s Food Traceability Rule To Track Food From Farm to Table

Newsletter, October 8, 2020

An EUA Fueled by Trump’s Treatment Sets Another Bad Precedence

FDA Celebrates Cybersecurity Month With New Clarifications on Policy

Newsletter, October 15, 2020

FDA Expects the Pandemic to Create Opportunity to Improve Cancer Trials

Covid Vaccine Trials Highlight the Challenges to Recruit Minorities

Newsletter, October 29, 2020

The October Surprise? Covid Vaccines Will Not Be Expedited by an EUA - Dr. Peter Marks, FDA

FDA Does Not Regulate Telemedicine or Intends to

Newsletter, November 5, 2020

Gilead’s PRV Highlights Another Financial Windfall Coming to Covid Vaccine Developers

Industry Payments to Doctors Continue Despite the Sunshine Act Disclosures

Newsletter, November 12, 2020

Five Ways Pfizer’s Covid Vaccine Changes the Life For All Other Covid Vaccines

About 90% of Clinical Data Used for FDA Approval is From Non-US Sites

Newsletter, November 19, 2020

And then there were 2 (or 4): Which Covid Vaccines Holds Most Promise?

FDA Report: Unregulated Medical Apps Significantly Improve Health Outcomes

Newsletter, December 3, 2020

Covid Vaccine Next Week? Non-US Approval and FDA

The Fate of the Second, Third, and Later Covid Vaccines In Jeopardy

Newsletter, December 10, 2020

Gut Microbiome Related to Depression: Regulatory Implications

Its All In the Name: FDA Releases Two Guidances for Proprietary Names

Newsletter, December 17, 2020

The Gifts of the Pandemic: Looking for the Silver Lining? Yes, There is One.

The Penalties of The Pandemic: Pain Points That Intend to Stay

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