FDAMap News 2020

​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)

Newsletter - December 10, 2020 (Gut Microbiome Related to Depression: Regulatory Implications; It’s All in the Name: FDA Releases Two Guidances for Proprietary Names)

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 - 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 - 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 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 - 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 - 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 8, ​2020 (An EUA Fueled by Trump’s Treatment Sets Another Bad Precedence | FDA Celebrates Cybersecurity Month with New Clarifications on Policy)

Newsletter - October 1, ​2020 (FDA Tightens ANDA Review and Rejection Timelines | FDA’s Food Traceability Rule to Track Food from Farm to Table)

Newsletter - September 24, 2020 (Off-Label Promotion by Manufacturers: FDA Modifies Rules for Enforcement | FDA Creates a New Center for Digital Health Products)

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 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 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 - August 27, 2020 (FDA has for Forever Tainted Plasma Treatment for COVID with Bad Politics | HHS Clarifies that FDA Cannot Regulate LDTs)

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 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 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 - July 30, 2020 (The Coronavirus Billionaires: Are the Taxpayers Getting a Fair Deal? | Getting Celebrity Testimonials to Push the Envelope for Promising Products)

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 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 9, 2020 (Too Many COVID Clinical Trials Creating “Traffic Jams” | What is the Actual Cost of Clinical Trials)

Newsletter - June 25, 2020 (Gottlieb and McClellan Critique FDA’s Requirements for COVID Clinical Trials | Stem cell clinics should file an IND, Now)

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 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 - 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 - May 21, 2020 (Moderna and Gilead Teach the “Value for Speed” in Pharma | Physician’s Perspective in Using Clinical Trials Data in Patient Cares)

Newsletter - May 14, 2020 (FDA Releases a Checklist of Restaurants Looking to Re-Open | Patient-Funded Clinical Trials Are an Option for 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 - 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 16, 2020 (Pandemic is Boom Time of Digital Health Companies | How Easy is it to Get an IND from FDA for a COVID-19 Drugs?)

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 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 - March 26, 2020 (India Bans Export of COVID-19 Related Products, Can You Rescind an Orphan Designation? Lessons from Gilead-FDA)

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 12, 2020 (FDA Suspends GMP Inspections But All Other Tasks Continue, Academic Research INDs to Follow CTD Format: FDA Guidance)

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 - February 27, 2020 (Peer Reviewed Publications Mostly Lack Raw Data, Government Reports List Ways to Reduce Admin Burden of Electronic Medical Records)

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 13, 2020 (Buying Patient Opinion at FDA Advisory Committee Meetings is the Norm,Companies Buying Health Data for Developing Products Should Pay Patients)
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Newsletter - February 06, 2020 (Why Do Academic Centers Fail at Timely Submitting Results to Clinicaltrials.gov? Solutions to Increase Reliability of Clinical Trial Data from Wearable Devices)
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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 - 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 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 9, 2020 (Faster Approval Rates Show Increased FDA-Industry Collaboration, Healthcare Administrative Costs are Three Times the Cost of Drugs)