+1 410-501-5777

info@fdamap.com

Icon-instagram-1 Threads Icon-facebook Icon-linkedin
Contact Us

Newsletter Archive 2022

Newsletter, January 6, 2022

Facebook Changes Ad Policies for Clinical Trials

FDA Releases Guidance for Wearables and Apps in Clinical Trials

Newsletter, January 20, 2022

Investigator Gets FDA Warning Letter for Not Retaining Trial Documents

FDA Extends Remote Inspection of Non-Critical Facilities

Newsletter, January 27, 2022

FDA Suggested Ways For Including Patient Perspectives in Clinical Trials

FDA’s New Approvals Were Not Affected by the Pandemic

Newsletter, January 13, 2022

FDA Provides Suggestions for Point-of-Care 3D Printing of Devices

FDA Provides Guidance on Histopathology Review for Non-clinical Studies

Newsletter, February 2, 2022

Mark Cuban Tests If A Compounding Pharmacy Can be a Generic Manufacturer

Virtual Patient-Doctor Interactions for Care and Clinical Trials Should Stay

Newsletter, February 10, 2022

FDA Pushes Back on Drug Approval Based on 100% Clinical Data from China

FDA Will Start Unannounced Inspections in India and China “Soon”

Newsletter, February 17, 2022

No, FDA Did Not Stop Accepting Clinical Data from China, But…

Is Digital Medicine Bust? Lessons from Akili

Newsletter, March 3, 2022

Is There is a Bi-Partisan Push for FDA To Regulate LDTs?

FDA Releases Multiple Guidance Documents Specific to Cancer Clinical Trials

Newsletter, March 10, 2022

FDA Has Stopped Accepting Covid Related EUAs, It Seems.

At-Home Diagnostics Post-Pandemic

Newsletter, March 17, 2022

For Demographic Diversity in Clinical Trials, Go to Non-US Sites

FDA Concludes that Cell Phones Don’t Cause Cancer in Children

Newsletter, March 24, 2022

FDA Provides Specifics For the Recall Process

When Will the Pandemic End and Will FDA Ever Go Back to 2019 Practices?

Newsletter, March 31, 2022

US Companies Prefer FDA Approval Over CE Mark for Medical Devices

You Cannot Sue Somebody For Criticizing Your Product, Even if Unfair

Newsletter, April 7, 2022

IS FDA Ready to Make Another Sarepta- and Biogen-Like Decision?

Does FDA Have a Double-Standard for Review for China-Only Data?

Newsletter, April 14, 2022

FDA Wants Sponsors to Submit Diversity Recruitment Plans in INDs and IDEs

FDA’s Defines Complex and Non-Complex Drugs for Generics Development

Newsletter, April 21, 2022

On LDTs, FDA Punts it Back to Patients and Panders the Politicians

Political Interference at FDA Is Under-Reported: GAO

Newsletter, April 28, 2022

FDA “Approves” E-Cigarettes Acknowledging That They Can Help Smokers Quit

Why Are Companies Still “Developing” New Covid Vaccines?

Newsletter, May 5, 2022

FDA Continued Increased Remote Inspections in 2021

Why FDA Is Sluggish in Regulating Illegal Promotion of Products on TV?

Newsletter, May 12, 2022

Can Food Be Treated as Medicine and Prescribed by Doctors?

CBD is a Drug: Says Another FDA Warning Letter to CBD Seller

Newsletter, May 19, 2022

From GMP to “EMP”: FDA to Create a Reward System for Manufacturers

What Does “FDA Approved” Mean, and Who Can Use This Phrase?

Newsletter, June 2, 2022

FDA and EMA Inspectors Found Similar Issues at GCP Inspections

The Speed of Covid Vaccine Development is an Exception, Not the New Norm

Newsletter, June 9, 2022

FDA Will Allow EUA Data To be Reused for Full Approval

Is There Room for Another Covid Vaccine: Novavax Becomes the Test

Newsletter, June 16, 2022

Is FDA In a Bind With the Canadian Approval for the ALS drug?

FDA Releases an Updated List of Approved Drugs with No Generics

Newsletter, June 23, 2022

Dietary Supplements for Cardiovascular Disease and Cancer?

FDA Relies on Equivalent Foreign Regulatory Agencies for Food Quality in the US

Newsletter, June 30, 2022

Breakthrough Therapy Designation is Not Permanent: FDA Guidance Emphasizes

Scientific Data Versus Anecdotes: What Role Should They Play in FDA Decisions

Newsletter, July 7, 2022

FDA Defines Parties Involved in Manufacture and Distribution of Drugs

The RMAT Designation Seems To Be Tougher Than the BTD

Newsletter, July 14, 2022

Indian Companies Dominate Competitive Generic Approvals by FDA

Benefits of the Compassionate Use Programs for Developers

Newsletter, July 21, 2022

FDA Now Accepts Medical Device Applications Electronically

How to Create FDA Acceptable IFU: New Guidance

Newsletter, July 28, 2022

FDA Limits Extensions on CRL Responses for ANDA

FDA Formalizes Remote Audit Practices via a New Guidance Document

Newsletter, August 11, 2022

Clinicaltrials.gov is Full of Errors About Study Timelines

FDA: Safety Reports for BA/BE Studies Must Also be Submitted Electronically

Newsletter, August 18, 2022

Can Pediatric Dosing be Extrapolated From Adult Dosing? FDA Suggests Ways

How Expensive is Too Expensive: Gene Therapy Treatment to Test The Waters

Newsletter, August 25, 2022

FDA Clarifies Rules for Charging Patients to Participate in Your Clinical Trial

FDA Eases Exporting Unapproved Medical Devices Using Self-Certified Letters

Newsletter, September 1, 2022

Court Rules Autologous Stem Cell Therapy Legal in a Rebuke to the FDA

Newsletter, September 8, 2022

Questions Raised About the Benefits of the Accelerated Approval Pathway

Inadequate Inspections and QA Oversight Dominate FDA 483s for GMP Sites

Newsletter, September 15, 2016

Importance of Cover Letters in Directing FDA Staffs’ Review of Applications

FDA Recommends Risk-Based Approach for Software Quality Assurance

Newsletter, September 22, 2022

FDA Will Only Accept 510k Submissions Electronically

Is the Pandemic Over?

Newsletter, September 29, 2022

Stop Sending EUAs for Covid Diagnostics: FDA

FDA Highlights Challenges of Conducting Clinical Trials in Children

Newsletter, October 6, 2022

A New Bill in the US Congress Aims to Reduce Animal Testing. Will it Work?

FDA’s List of AI and Machine Learning Devices in an Invaluable Gift

Newsletter, October 13, 2022

Double-Blinding Author Names Suggested to Address Bias in Peer-Review

Harmonization of Clinical Trial Rules for Private and Public Funded Clinical Trials

Newsletter, October 20, 2022

FDA Starts A New Limited Program for Advancing RWE

Off-Label Use of Diabetes Drug for Weight Loss: Anecdotes to RWE

Newsletter, October 27, 2022

FDA Provides Guidance of Using Multiple Endpoints in Clinical Trials

Critical Deficiency in AI-Enabled Medicine Limit their Practical Application

Newsletter, November 3, 2022

FDA Provides Guidance on Expanded Access Program

Clinical Trials at Your Neighborhood Walmart

Newsletter, November 10, 2022

FDA’s Rules Prohibit Tissue Collection from LGBTQ+ and African Donors

Same Drug Different Outcomes in Breakthrough Designation at FDA and EMA

Newsletter, November 17, 2022

Indian Regulators Cut Corners to Expedite Indian Covid Vaccine: So, What?

FDA Releases Updated Cybersecurity Playbook

Newsletter, December 1, 2022

FDA Updates List of Approved Medical Device Development Tools

Newsletter, December 8, 2022

Cancer Clinical Trial Data is Rarely Made Public

Independent Panel Recommends Significant Changes to Food Regulation by FDA

Newsletter, December 15, 2022

FDA’s Digital Health Navigator

Clinical Trials Cannot be Done Without an FDA-Cleared IND

FDA Purán Newsletter Signup

Subscribe to FDA Purán Newsletter for 
Refreshing Outlook on Regulatory Topics

One-stop source for FDA consultation, regulatory affairs training, and clinical trial services.

Icon-instagram-1 Threads Icon-facebook Icon-linkedin

Services

Company

Support

Copyright © 2025 FDAMap.com. All rights reserved.