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Newsletter Archive 2017

​Newsletter, January 7, 2017

What Can We Expect From FDA This Year Based What We Saw Last Year

Newsletter, January 12, 2017

Hacking Risks for Medical Devices with Internet Connectivity

Limitation of Real World Evidence Highlighted by Physician Survey

Newsletter, January 19, 2017

FDA Faces Many Challenges in Auditing Foreign GMP Sites

Convert or Inactivate DMFs Before the May Deadline for Electronic DMFs

Newsletter, January 26, 2017

Buying Public Opinion: Conflict of Interest and Discussions about Drugs

Data Integrity Issues in Clinical Trials due to Fraud by Patients

Newsletter, February 9, 2017

Potential of Wearable Devices for Adverse Event Monitoring in Clinical Trials

Newsletter, February 16, 2017

Compassionate Use Rules are Better Than the “Right to Try” Laws

Most Drug Approvals by FDA are Based on Clinical Trials in White People

Newsletter, March 2, 2017

FDA Under Attack: Can Industry Help?

India is the Main Non-US Producer of Prescription Drugs

Newsletter, March 9, 2017

Over-Hyped Scientific Literature and FDA-Regulated Industry

Old Medicine, New Concerns: Should Hospitals Sell Alternative Medicine?

Newsletter, March 16, 2017

Increased Patient Engagement by FDA and Its Impact on Industry

FDA Has Many Measures to Avoid Conflict of Interest

Newsletter, March 23, 2017

Special GMP for Cell Therapy Products: European Draft Guidance Gets Mixed Reviews

Time to Approval of 505(b)(2) NDAs is Shorter Than Conventional NDAs

Newsletter, March 24, 2017

Opiate Regulation Gets a Major Makeover

Breakthrough Designation Speeds Up Approval but Strains FDA’s Resources

Newsletter, March 30, 2017

FDA Audit Processes to Change Dramatically in May

Major Data Integrity Violations Exposes Flaws in the Regulatory Process

Newsletter, April 6, 2017

Off-Label Promotion Gets Political Support But Is It Good For Consumers?

FDA Does Not Regulate Smartphone Apps, But Courts and FTC Do

Newsletter, April 20, 2017

Should Medical Food Clinical Trials be Conducted Under INDs? May

What Are the Most Common GMP Deficiencies Found by FDA?

Newsletter, April 27, 2017

FDA’s Action-Inaction About Unapproved Drugs

How Much Diversity is Required for FDA Approval?

Newsletter, May 4, 2017

Using Foreign Vendors? FDA’s Warning Letter Points A Common Issue

FDA and NIH Release the Best Free Tool to Write Clinical Protocols

Newsletter, May 5, 2017

Data Integrity and Theranos: Lessons from the Extreme Non-Compliance

Retracted Research Articles and Research Integrity

Newsletter, May 11, 2017

Clinical Trials Cannot Catch All Side Effects of Drugs; Should We Worry?

Privacy Concerns Limit Use of Genetic Data from DTC Tests

Newsletter, May 18, 2017

Hacking of Computers in FDA Regulated Industries Exposes Common Flaw

NIH Limits on Grants to Investigators: First Step to Improve Distribution of Taxpayer Money

Newsletter, May 25, 2017

Two Unique Approvals in a Week; FDA’s Baby Steps, Industry’s Giant Leap

Janet Woodcock Pulled a Frances Kelsey and Everyone is Mad

Newsletter, June 1, 2017

Fidget Spinner: Should FDA Regulate or Leave Them Alone?

FDA is Very Worried Device Cybersecurity and So Should Be We

Newsletter, June 8, 2017

Google Search Trends And Personal Health Management

Medical Devices for Rare Diseases No Longer Need to Use Local IRBs

Newsletter, June 15, 2017

NIH’s Knee-Jerk Reversal on Policy for Grants Limitation Raises New Questions

As Developers Push the Envelope with Smartphone Apps, FDA May Step Up too

Newsletter, June 22, 2017

FDA’s Guidance Lists Best Practices For Using Electronic Systems in Clinical Trials

Coconut Had A Bad Week But We All Got A Lesson in Food Health Claims

Newsletter, June 29, 2017

FDA Pushes Generics In A Not-So-Indirect Effort to Control Drug Prices

Clinical Trial Endpoints Using Mobile Phones: Still A Lot of Ways to Go

Newsletter, July 13, 2017

Why is India a Great Location for BA/BE Studies But Not For Clinical Trials?

Innovative Trial Design to Speed Up FDA Approval

Newsletter, July 20, 2017

FDA Speeds Up Public Disclosure of Approval Decisions

Newsletter, July 27, 2017

FDA Looks Forward to Consumer Complaints to Rein In Supplements

Does Empowering Patients Mean “Better” Regulation of Drugs by FDA?

Newsletter, August 3, 2017

FDA’s Takes A Developer-Friendly Approach to Regulating Software

Automated System Improves FDA Clearance of Imports as Expected

Newsletter, August 10, 2017

The Promise and Perils of the Pre-Cert Program for Software Developers

FDA Explains What Is a Minor Change in Biologics Manufacturing: Core Principle for All GMP Process Changes

Newsletter, August 17, 2017

Recruitment Issues with Cancer Trials Lead to Innovative Regulatory Scenarios

FDA’s Accelerated Approval Challenged, But Is it Fair to Blame the Agency?

Newsletter, August 24, 2017

The Gray Area in FDA Regulation of Celebrity Endorsement of Drugs

FDA Updates Registration Requirements For Everybody Involved in Drug Distribution

Newsletter, August 31, 2017

No, FDA Did Not Change Stem Cell Regulations with One Announcement

Why Is Google’s Clinical Depression Tool Not a FDA-Regulated Medical Device?

Newsletter, September 7, 2017

The Practical Implications of FDA and EMA Sharing Confidential GMP Information

FDA Explains What is Real World Evidence and How It Can Be Used

Newsletter, September 14, 2017

Can FDA Do Anything About The Price of Drugs to Consumers?

Expedited FDA Approval Leads to Unsafe Drugs? No.

Newsletter, September 21, 2017

Can FDA Regulate Stem Cell Companies if State Laws Allow Them?

FDA Needs Consumers’ Help to Rein-in Online Pharmacies

Newsletter, September 28, 2017

Is FDA Getting Impatient with Conventional Clinical Trials?

FDA Approvals Predominantly Based on Data Lacking Minority Subjects in Clinical Trials

Newsletter, October 5, 2017

California Does What FDA Can’t: Require Unapproved Stem Cell Clinics to Inform Patients

FDA Relaxes eCTD Format to Give More Flexibility to Applicants

Newsletter, October 12, 2017

FDA’s “Love”-Less Warning Letter to a Boston Bakery: Food GMP Overkill?

CTTI Suggests Ways To Reduce “One And Done” Clinical Investigators

Newsletter, October 19, 2017

FDA’s Audit Manual Updated: Surprisingly No Surprising Changes

Orphan Drug is Generally Not the First Step to Non-Orphan Approval

Newsletter, November 2, 2017

Physician’s Perspective on Simplifying Clinical Trials

FDA Follows Through on its Promise to Recognize European GMP Audits

Newsletter, November 9, 2017

FDA Exempts Most DTC Genetics Tests From 510k

Menu Labeling Simplified by FDA

Newsletter, November 16, 2017

Can False General Health Genetic Tests Hurt the Consumer?

Real World Testing Data and FDA Acceptance of Real World Evidence

Newsletter, November 30, 2017

No, FDA Did Not Change Stem Cell Regulations As Advertised

Widely Available Supplements Contain Unapproved Drugs

Newsletter, December 7, 2017

FDA Takes Unconventionally Hands-On Role to Approve New Technology

Regenerative Medicine and FDA: Echo Chamber or Calm Before the Storm?

Newsletter, December 14, 2017

FDA’s Relaxed Software Regulations Opens Doors to The Digital Doctor

FDA Measures for Early Feasibility Studies for Devices Bears Fruit

Newsletter, December 21, 2017

Least Burdensome Approach: FDA Says Do Less to Succeed More

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