FDAMap News 2017

Newsletter - December 21, 2017 (Least Burdensome Approach: FDA Says Do Less to Succeed More)

​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 7, 2017 (FDA Takes Unconventionally Hands-On Role to Approve New Technology | Regenerative Medicine and FDA: Echo Chamber or Calm before the Storm?)

​Newsletter - November 30, 2017 (No, FDA Did Not Change Stem Cell Regulations As Advertised | Widely Available Supplements Contain Unapproved Drugs

​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 9, 2017 (FDA Exempts Most DTC Genetics Tests From 510k | Menu Labeling Simplified by FDA  )

Newsletter - November 2, 2017 (Physician’s Perspective on Simplifying Clinical Trials | FDA Follows Through on its Promise to Recognize European GMP Audits)

Newsletter - October 26, 2017 (Compounding Pharmacy Openly Flouts FDA Regulations | FDA’s Tacit Encouragement of Interchangeability of Biosimilars)

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 - 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 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 - September 28, 2017 (Is FDA Getting Impatient with Conventional Clinical Trials? | FDA Approvals Predominantly Based on Data Lacking Minority Subjects in Clinical Trials)

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 14, 2017 (Can FDA Do Anything About The Price of Drugs to Consumers | Expedited FDA Approval Leads to Unsafe Drugs? No.)

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 - 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 - 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 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 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 3, 2017 (FDA Takes a Developer-Friendly Approach to Regulating Software | Automated System Improves FDA Clearance of Imports as Expected)

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 - July 20, 2017 (FDA Speeds Up Release of Drug Approval Information | Should Drugs Be Used After Expiration Dates to Manage Cost of Healthcare?)

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 - June 29, 2017 (FDA’s 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 - 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 15, 2017 (NIH 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 8, 2017 (Google Search Trends and Personal Health Management | Medical Devices for Rare Diseases No Longer Need to Use Local IRBs)

Newsletter - June 1, 2017 (Fidget Spinner: Should FDA Regulate or Leave Them Alone | FDA is Very Worried Device on Cybersecurity and So Should Be We)

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 - 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 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 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 - April 27, 2017 (FDA’s Action-Inaction About Unapproved Drugs | How Much Diversity is Required for FDA Approval?)

Newsletter - April 20, 2017 (Should Medical Food Clinical Trials be Conducted Under INDs? May be | What Are the Most Common GMP Deficiencies Found by FDA?)

Newsletter - April 13, 2017 (FDA’s Paradigm Shifting Approval of the First “Non-Diagnostic” Test | Who is Faster in Approving FDA or EMA and Why should it Matter)

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 - March 30, 2017 (FDA Audit Processes to Change Dramatically in May | Major Data Integrity Violations Exposes Flaws in the Regulatory Process)

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 16, 2017 (Increased Patient Engagement by FDA and Its Impact on Industry | FDA Has Many Measures to Avoid Conflict of Interest)

Newsletter - March 9, 2017 (Over-Hyped Scientific Literature and FDA-Regulated Industry | Old Medicine, New Concerns: Should Hospitals Sell Alternative Medicine?)

Newsletter - March 2, 2017 (FDA Under Attack: Should Industry Help? | India is the Main Non-US Producer of Prescription Drugs)

Newsletter - February 23, 2017 (EMA Raises Concerns with Use of Electronic Systems in Clinical Trials | Small Companies Use Smart Strategies to be Successful with FDA)

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 - February 9, 2017 (Potential of Wearable Devices for Adverse Event Monitoring in Clinical Trials)

Newsletter - February 2, 2017 (No New FDA Regulations Means Keeping the Status Quo | Bringing Manufacturing to the US Will Not Reduce Drug Prices)

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 - 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 12, 2017 (Hacking Risks for Medical Devices with Internet Connectivity | Limitation of Real World Evidence Highlighted by Physician Survey)

Newsletter - January 5, 2017 (What Can We Expect From FDA This Year Based What We Saw Last Year)