FDAMap News 2019

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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Newsletter - December 5, 2019 (FDA Releases an Updated Guidance for Adaptive Trials, The Conundrum of CBD Products for Medical Professionals)
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​Newsletter - November 21, 2019 (Lessons from the Dollar Tree Warning Letter, Two FDA Breakthrough Drug Approvals Highlight Progressive Regulators)
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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 7, 2019 (FDA Review Needed to Address Bias in Health Algorithms, Reorganization of FDA’s Oncology Products Reviewers Affects IND and NDAs)

Newsletter - October 31, 2019 (Is FDA Ignoring Complaints About Generic Drug Quality? FDA’s Solutions to Counter Drug Shortage – Increased Drug Prices)

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 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 10, 2019 (FDA Argues That Expedited Approval Does Not Change Requirements, FDA Provides Advice on How to Find What the Patients Want)

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 - September 26, 2019 (Novartis Uses “Dog Ate My Homework” Strategy with FDA; Will It Work? | AI is As Good As Humans to Interpret Diagnostics)
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Newsletter - September 19, 2019 (First They Came For The.... Chinese-American Scientists in the US, We Are Getting Better at Treating Cancer)

Newsletter - September 12, 2019 (Right-To-Try is Practically Dead, How Does Apple Change Clinical Trials?)

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)
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Newsletter - August 29, 2019 (Just Because it is Sold on Amazon, Does not Mean it is Legal. FDA Explains the Expectations

Newsletter - August 22, 2019 (Did Sarepta Expose the Flaw in FDA Review Process? | FDA Updates Clinical Endpoint List to Help Others Design Better 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 1, 2019 (FDA Offers Practical Tips on How to Address CMC for BTD Products | FDA’s Quality by Design (QBD) Guidance for Clinical Trials)
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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 - July 18, 2019 (FDA and EU Finish cGMP Inspection Integration | Diagnostic Errors Are Mostly Due to Clinical Judgement: Opportunity for AI)

Newsletter - July 11, 2019 (Conflict of Interest and FDA’s Revolving Door | Expedited FDA Approvals are Now the Norm)

FDAMap Newsletter June 28, 2019 (RWE for Diversity in Clinical Data | Is India a New Destination for Medical AI Development?)

FDAMap 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)

FDAMap 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?)

FDAMap Newsletter June 6, 2019 (RTT Fizzles While FDA Increases Support for Compassionate Use Program | Does FDA Support Industry Charging High Prices for New Drugs?)

FDAMap Newsletter May 30, 2019 (Industry Analysts Predict Digital Technologies Will Transform Healthcare | FDA Advocates Ways to Reduce Food Waste)

FDAMap 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)

FDAMap 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)

FDAMap 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)

FDAMap 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)

FDAMap 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)

FDAMap Newsletter April 18, 2019 (FDA Lists Four Unlawful Ingredients in Supplements | Should Patients Participating in Trials Get Free Drugs Post Approval)

FDAMap 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)

FDAMap Newsletter April 4, 2019 (FDA Touts Benefits of Compassionate Use | Another FDA Announcement for Regulation of Stem Cell Treatments)
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FDAMap Newsletter March 28, 2019 (FDA Suggests Alternates to Placebo Control for Pivotal Clinical Trials | Need Minority Patients in Your Trials, Find Minority Investigators)

FDAMap Newsletter March 21, 2019 (Do You Trust FDA to Assure Safety Of Approved Products | FDA Would Like Sponsors to Modernize Clinical Trials)

FDAMap 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)

FDAMap Newsletter March 7, 2019 (FDA Comes to the Defense of India-Based Manufacturers | Keep Using Expired Forms Unless FDA Says Otherwise)

FDAMap Newsletter February 28, 2019 (FDA Increases Oversight of Imported Food | With BTD Comes More Responsibility. . to Maximize Benefit)

FDAMap Newsletter February 21, 2019 (Study Tries to Explain Poor Patient Recruitment Rates | Before Responding to 483 Findings, Ask FDA for Concurrence)

FDAMap 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)

FDAMap Newsletter February 7, 2019 (FDA Explains How to Do Less to Get More: Least Burdensome Approach | FDA’s Combination Product Guidance Clarifies Common Questions)

FDAMap Newsletter January 31, 2019 (FDA Announces Several Initiatives to Encourage Real World Evidence | FDA Updates Orange Book and Rules for Complex Generics)

FDAMap 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)

FDAMap 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)

FDAMap 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)