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Newsletter Archive 2019

Newsletter, January 10, 2019

Living with the Shutdown: What’s Still On at FDA and What’s on Hold

FDA Starts to Turn the Screws on the Stem Cell Clinics

Newsletter, January 17, 2019

FDA Expects More Than 200 new INDs for Cell Therapy Products Next Year

FDA Continues Critical Audits During the Government Shutdown

​Newsletter, January 24, 2019

Best Buy as a (Digital) Drug Store: The Age of Digital Medicine Has Arrived.

Is China Systematically Stealing US Intellectual Property?

Newsletter, January 31, 2019

FDA Announces Several Initiatives to Encourage Real World Evidence

FDA Updates Orange Book and Rules for Complex Generics

Newsletter, February 7, 2019

FDA Explains How to Do Less to Get More: Least Burdensome Approach

FDA’s Combination Product Guidance Clarifies Common Questions

​Newsletter, February 14, 2019

FDA Would Like to Increase Regulation of Dietary Supplements But Can it?

Youth E-Cigarette Use On the Rise Despite FDA’s Effort to Curtail it

Newsletter, February 21, 2019

Study Tries to Explain Poor Patient Recruitment Rates

Before Responding to 483 Findings, Ask FDA For Concurrence

Newsletter, February 28, 2019

FDA Increases Oversight of Imported Food

With BTD Comes More Responsibility. . to Maximize Benefit

Newsletter, March 7, 2019

Can One Claim “100% Approval Rate” for Their NDA for a New Drug?

Getting BTD is Not Sufficient to Get Value

Newsletter, March 14, 2019

FDA Pushes for Relaxed Patient Inclusion Criteria for Cancer Trials

Patients Get More Access to FDA Via a New Formal Meeting Requests

Newsletter, March 21, 2019

Do You Trust FDA to Assure Safety Of Approved Products?

FDA Would Like Sponsors to Modernize Clinical Trials

Newsletter, March 28, 2019

FDA Suggest Alternates to Placebo Control for Pivotal Clinical Trials

Newsletter, April 4, 2019

FDA Touts Benefits of Compassionate Use

Another FDA Announcement for Regulation of Stem Cell Treatments

Newsletter, April 11, 2019

Silly Mistakes Lead to Refuse to File From FDA for Breakthrough Therapy

GAO Wants FDA to Assess its Foreign Inspections for Drugs and Food

Newsletter, April 18, 2019

FDA’s Lists Four Unlawful Ingredients in Supplements

Should Patients Participating in Trials Get Free Drugs Post Approval

Newsletter, April 25, 2019

FDA’s Approval of a Novel ADHD Devices Sheds Light on Regulatory Process

Peer Reviewed Publications by FDA and Other Government Agencies

Newsletter, May 2, 2019

Update Your Bookmarks, FDA Has a New Website

Do CROs Over-Complicate Clinical Trials? An Opinion By a PI Presents Challenges

Newsletter, May 9, 2019

FDA’s “New” Guidance for Medical Device Meetings: Old Info in New Package

Real World Data in INDs and NDAs: FDA’s Guidance Provides Little Help

Newsletter, May 16, 2019

FDA Is Increasingly Approving Drugs Based on One Clinical Trial Only

FDA Presents its Annual Report on Drug GMP: All is Average

Newsletter, May 23, 2019

Most People Prefer Talking to Their Doctors Over Online Review of Health Info

GMP Inspections by FDA and All Countries in the EU to Equalize By 15 July 2019

Newsletter, May 30, 2019

Industry Analysts Predict Digital Technologies Will Transform Healthcare

FDA Advocates Ways to Reduce Food Waste

Newsletter, June 1, 2016

Drug Approvals in EU and US: Harmonization of Rules at FDA and EMA

Is the Use of Wearable Devices in Clinical Trials Over-Hyped?

Newsletter, June 6, 2019

RTI Fizzles While FDA Increases Support for Compassionate Use Program

Does FDA Support Industry Charging High Prices for New Drugs?

Newsletter, June 13, 2019

Clinicaltrials.gov Has a Loophole that NIH and FDA Need to Close

Should FDA Disclose Submission of NDA and BLA Applications?

Newsletter, June 20, 2019

FDA’s Enforcement Discretion on CBD Creates Confusion for Consumers

Alexa To Detect Cardiac Arrest: Software-based Diagnostics In Every Home

Newsletter, June 27, 2019

RWE for Diversity in Clinical Data

Is India a New Destination for Medical AI Development?

Newsletter, July 11, 2019

Expedited FDA Approvals Are Now the Norm

Conflict of Interest and FDA’s Revolving Door

Newsletter, July 18, 2019

FDA and EU Finish cGMP Inspection Integration

Diagnostic Errors Are Mostly Due to Clinical Judgement: Opportunity for AI

Newsletter, July 25, 2019

CBD and Stem Cells Show How FDA‘s Enforcement Discretion is Misused by All

Early Adopters of Smartphone-Based Healthcare Show Interesting Trends

Newsletter, August 1, 2019

FDA Offers Practical Tips on How to Address CMC for BTD Products

FDA’s Quality By Design (QBD) Guidance for Clinical Trials

Newsletter, August 15, 2019

FDA Takes Measures to Clean Its Drug Registration Database in 30 Days

Is Novartis a Victim or the Villain: Perhaps Both?

Newsletter, August 22, 2019

Did Sarepta Expose the Flaw in FDA Review Process?

FDA Update Clinical Endpoint List to Helps Others Design Better Clinical Trials

Newsletter, August 29, 2019

Just Because it is Sold on Amazon, Does not Mean it is Legal.

FDA Explains the Expectations from cGMP Compliant Facilities

Newsletter, September 5, 2019

Drugs Approvals by FDA Do Not Require Diversity in Clinical Trials

FDA Presents a Glimpse of Upcoming Stem Cell Regulation with a New WL

Newsletter, September 12, 2019

Right-To-Try is Practically Dead.

How Does Apple Change Clinical Trials?

Newsletter, September 19, 2019

First They Came For The…… Chinese-American Scientists in the US..

We Are Getting Better at Treating Cancer

Newsletter, September 26, 2019

Novartis Uses “Dog Ate My Homework” Strategy with FDA; Will It Work?

AI is As Good As Humans to Interpret Diagnostics

Newsletter, October 3, 2019

FDA Reorganization Highlights New Realities for the Industry

23 & Me Gets Into Clinical Trial Recruitment Testing the Privacy of Consumers

Newsletter, October 10, 2019

FDA Argues That Expedited Approval Does Not Change Requirements

FDA Provides Advise on How to Find What the Patients Want

Newsletter, October 17, 2019

The Power of One: Using One-Patient Trials for FDA Approval

For FDA Acceptance of Real World Data Do Better Observational Studies

Newsletter, October 24, 2019

Healthcare Apps Pose Several Safety Concerns to Users

FDA Warns Another CBD Manufacturer But Does it Address the Broader Issue

Newsletter, October 31, 2019

CBD and Stem Cells Show How FDA‘s Enforcement Discretion is Misused by All

FDA’s Solutions to Counter Drug Shortage – Increased Drug Prices

Newsletter, November 7, 2019

FDA Review Needed to Address Bias in Health Algorithms

Reorganization of FDA’s Oncology Products Reviewers Affects IND and NDAs

Newsletter, November 14, 2019

Who Owns Your Medical Data? Apparently Not You…

FDA Tells What To Do When The Export Certificate is Denied.

Newsletter, November 21, 2019

Lessons from the Dollar Tree Warning Letter

Two FDA Breakthrough Drug Approvals Highlight Progressive Regulators

Newsletter, December 5, 2019

FDA’s Releases an Updated Guidance from Adaptive Trials

The Conundrum of CBD Products for Medical Professionals

Newsletter, December 12, 2019

FDA’s Foreign GMP Audits Are Inadequate, Reports GAO

Use of Digital Devices in Clinical Trials Increased About 6 Folds in Last 10 Years

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