FDA Puran: Our Unique Perspective on News of Global Pharma & Healthcare Industry

Latest News

Newsletter, September 28, 2023 (FDA Clarifies Meeting Types and Other Details in a New Guidance on Meetings | FDA’s Cybersecurity Requirements for Medical Devices)

Recent News

Newsletter, September 21, 2023 (Market Approval Based on a Single Clinical Trial is Possible, But…: FDA | FDA Rejects AdCom Recommendation for Approval of Nasal Epinephrine Spray)

Newsletter, September 14, 2023 (The Covid Boosters in the Post-Pandemic Age: Would Covid Be the New Flu? | FDA’s Clarifies its Expectations from IRB Review of Compassionate Use)

Newsletter, September 7, 2023 (FDA’s Latest Advice for Strategic Considerations for 510K Applications | FDA Funding for Orphan Drug Clinical Trials)

Newsletter, August 31, 2023 (FDA Releases Expectations for Using RWE in Support of New Drug Approvals | What You Should Know About the $1 Billion Taxpayer-Funded Covid Trial)
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Newsletter, August 24, 2023 (Pharma Connections in Patient Advocacy Leadership Raises Conflict of Interest Concerns | Should the FDA Increase Dietary Supplement Review)

Newsletter, August 17, 2023 (FDA’s New Post-Market Diversity Expectations | FDA Requirements for Using Off-The-Shelf Software in New Medical Devices)

Newsletter, August 10, 2023 (Did NIH Waste Almost a Billion Dollars Over 2.5 Years for an Observational Study? | FDA Registration of Cosmetic Manufacturing Facilities)

Newsletter, August 3, 2023 (Billions Wasted on Futile Onco Drug Development Indicates a Disturbing Trend | When Physicians Recruit Their Own Patients in Clinical Trials…)


Newsletter, July 27, 2023 (WHO’s Clinical Trial Guidance: Same Intent as FDA, With a Twist | FDA Creates a Certification for Foreign Food Suppliers: VQIP)

Newsletter, July 14, 2023 (Trends in FDA Approval of Breakthrough Devices | FDA Advise on Risk Assessment for Manufacturing Changes for HCT Products)

Newsletter, July 6, 2023 (Off-Label Marketing of Artificial Intelligence Based Software Devices | How Profitable Are the Rare Pediatric Disease Priority Review Vouchers?)

Newsletter, June 29, 2023 (FDA Clarifies Rules for Compounding Pharmacies to Plug a Loophole | FDA Presents Its Comprehensive Recommendations for DTC Ads)

Newsletter, June 22, 2023 (FDA Lists the Most Common GMP Deficiencies Last Year | Race-Based Disease Scores: Good for One, Not for The Other)

Newsletter, June 15, 2023 (Can Observational Studies Be Used for Supporting New Treatments | Should ChatGPT Be an Author on Scientific Papers Written with Its Help?)

Newsletter, June 8, 2023 (FDA Puts Its Weight Behind Virtual Clinical Trials | FDA Definition of Generally Accepted Scientific Knowledge: Will It Reduce Animal Studies?)
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Newsletter, June 1, 2023 (FDA Returns to In-Person Meetings Starting 12 June | FDA to Require New Patient-Friendly Medication Guides For all Drugs)

Newsletter, May 25, 2023 (FDA Provides Detailed Guidance on Developing Drugs for Children | Orphan Drugs are the Most Expensive Drugs in the US Market)

Newsletter, May 18, 2023 (Accelerated Approvals Benefit Companies Over Patients: Bloomberg | Clinical Trial Recruitment is Not Easy: CVS Learns the Hard Way)

Newsletter, May 11, 2023 (COVID Emergency Officially Ends Today but Not EUAs: FDA | FDA Discusses Regulatory Concerns for Use of AI in Drug Development)

Newsletter, May 4, 2023 (FDA Advises When to Do or Not Do Decentralized Clinical Trials | NIH-Funded Animal Research Without Ethical Compliance in Columbia)

Newsletter, April 27, 2023 (FDA Clarifies Electronic Submission of Veterinary Product Applications | EMA Describes Considerations for Single-Arm Studies for Oncology Drugs)

Newsletter, April 20, 2023 (Why is FDA Quiet About the Off-Label Promotion of Ozempic? Ozempic Vs Viagra | FDA’s Warning Letter Highlights Need for Pre-Approval of Device Modifications)

Newsletter, April 13, 2023 (FDA Finalizes Risk-Based Monitoring Guidance with Practical Advice | Digital Health Company’s Bankruptcy Highlights the Challenges of DM Products)

Newsletter, April 6, 2023 (Disclose Possibility of Early Termination in Informed Consent: IRB | Trial Does Not Meet the Primary Endpoint? No Worries, FDA Still Might Approve)

Newsletter, March 31, 2023 (FDA “New” Policy for Medical Devices with Cybersecurity Issues | Why Do We Still Need Primate Toxicity Studies?)

Newsletter, March 31, 2023 (FDA “New” Policy for Medical Devices with Cybersecurity Issues | Why Do We Still Need Primate Toxicity Studies?)

Newsletter, March 23, 2023 (FDA Updates the Medical Foods Guidance | Animal Drug Approval Based Only on Published Literature is Challenging)

Newsletter, March 16, 2023 (Survey Points to Challenges and Promise of Expanded Access Treatment | FDA Updates the Guidance for Electronic Records in Clinical Trials)

Newsletter, March 9, 2023 (FDA Raises Several Considerations for Use of AI in Drug Manufacturing | ChatGPT For Drug Development?)

​Newsletter, March 2, 2023 (FDA is Out of Touch With Patients’ Needs: A Former HHS Employee | When Your Vendor Screws Up: Pfizer and Care Access for Lyme Trial)

​Newsletter, February 23, 2023 (GAO Recommends That FDA Conduct More Robust Audit of IRBs | There is a Lack of Competition for API Manufacturers for Generic Drugs)

​Newsletter, February 16, 2023 (About Half of the New Drugs Approved by FDA Are Not So by Other Countries | FDA’s Guidance on Neonatal Product Testing Highlights Their Impossibility)


Newsletter, February 9, 2023 (FDA Remembers All Submissions: New Jersey Clinic Learned this Lesson | FDA Lists Four Expectations from Oncology Drug Developers)

Newsletter, February 2, 2023 (“Work from Home” No More: FDA Staff Returns to the Office This Month | FDA Audit Trends, 2023)
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Newsletter, January 26, 2023 (FDA Guidance on Clinical Trials with Cannabis: Same Info, Repackaged? | FDA Requirement for Clinical Trial Diversity Action Plans: Are They Useful?)

Newsletter, January 19, 2023 (FDA Updates the Clinical Protocol Template | FTC: Dietary Supplements Need Clinical Trials to Support Health Claims)

Newsletter, January 12, 2023 (FDA Brass Seems to Suggest US-Only Clinical Trials: Is it Practical or Fair? | Can Paying More to Participants Increase Diversity in Clinical Trials?) 

Newsletter, January 5, 2023 (Five Things That Changed Forever at FDA in 2022 | FDA’s First Warning Letter of the Year Highlights the Impossibility of Regulating Online Pharmacies) 

Newsletter, December 15, 2022 (FDA’s Digital Health Navigator | Clinical Trials Cannot be Done Without an FDA-Cleared IND)

Newsletter, December 8, 2022 (Cancer Clinical Trial Data is Rarely Made Public | Independent Panel Recommends Significant Changes to Food Regulation by FDA)

Newsletter, December 1, 2022 (FDA Updates List of Approved Medical Device Development Tools | CDC Revised Opioid Prescription Guidelines to Address Overkill)

Newsletter, November 17, 2022 (Indian Regulators Cut Corners to Expedite Indian Covid Vaccine: So, What? | FDA Releases Updated Cybersecurity Playbook)

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 3, 2022 (FDA Provides Guidance on Expanded Access Program | Clinical Trials at Your Neighborhood Walmart)

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, October 20, 2022 (FDA Starts a New Limited Program for Advancing RWE | Off-Label Use of Diabetes Drug for Weight Loss Anecdotes to RWE)
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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 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 is an Invaluable Gift)

Newsletter, September 29, 2022 (Stop Sending EUAs for Covid Diagnostics: FDA | FDA Highlights Challenges of Conducting Clinical Trials in Children)

Newsletter, September 22, 2022 (FDA will Accept 510k Submissions Only Electronically | Is the Pandemic Over?)

Newsletter, September 15, 2022 (Importance of Cover Letters in Directing FDA Staffs’ Review of Applications | FDA Recommends Risk-Based Approach for Software Quality Assurance)
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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 1, 2022 (Court Rules Autologous Stem Cell Therapy Legal in a Rebuke to the FDA | Who Will Regulate Stem Cell Therapy Clinics Now that FDA Can’t?)

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, 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 11, 2022 (Clinicaltrials.gov is Full of Errors About Study Timelines | FDA: Safety Reports for BA/BE Studies Must Also be Submitted Electronically)

Newsletter, July 28 2022 (FDA Limits Extensions on CRL Responses for ANDA | FDA Formalizes Remote Audit Practices via a New Guidance Document)

Newsletter, July 21, 2022 (FDA Now Accepts Medical Device Applications Electronically | How to Create FDA Acceptable IFU: New Guidance)

Newsletter, July 14, 2022 (Indian Companies Dominate Competitive Generic Approvals by FDA | Benefits of the Compassionate Use Programs for Developers)

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, 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, 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 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 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 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, 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, 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 5, 2022 (FDA Continued Increased Remote Inspections in 2021 | Why FDA is Sluggish in Regulating Illegal Promotion of Products on TV?)

​Newsletter, April 28, 2022 (FDA “Approves” E-Cigarettes Acknowledging That They Can Help Smokers Quit | Why Are Companies Still “Developing” New Covid Vaccines?)

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 14, 2022 (FDA Wants Sponsors to Submit Diversity Recruitment Plans in INDs and IDEs | FDA Defines Complex and Non-Complex Drugs for Generics Development)
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​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, 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, 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 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 10, 2022 (FDA Has Stopped Accepting Covid Related EUAs, It Seems. | At-Home Diagnostics Post-Pandemic)

Newsletter, March 3, 2022 (Is There a Bi-Partisan Push for FDA To Regulate LDTs? | FDA Releases Multiple Guidance Documents Specific to Cancer Clinical Trials)

Newsletter, February 17, 2022 (No, FDA Did Not Stop Accepting Clinical Data from China, But… | Is Digital Medicine Bust? Lessons from Akili)

​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 3, 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, 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 20, 2022 (FDA Provides Suggestions for Point-of-Care 3D Printing of Devices | FDA Extends Remote Inspection of Non-Critical Facilities)

Newsletter, January 13, 2022 (Investigator Gets FDA Warning Letter for Not Retaining Trial Documents | FDA Provides Guidance on Histopathology Review for Non-clinical Studies)

Newsletter, January 6, 2022 (Facebook Changes Ad Policies for Clinical Trials | FDA Releases Guidance for Wearables and Apps in Clinical Trials)

Newsletter, December 9, 2021 (Clinicaltrial.gov Website Gets a Facelift | FDA Updates the Clinical Outcome Assessment Compendium)

Newsletter, December 2, 2021 (If You Ever Wanted to File a FOI Request with FDA: Forget it. | Did the EUA for Covid Tests, Kill the 510k for them?)

Newsletter - November 18, 2021 (FDA’s EUA for Covid LDTs Has Minimal Impact on Most LDTs | The Revolving Door Turns a Full 360 degrees with Califf: Why Should We Care?)

Newsletter - November 11, 2021 (FDA May Soon Require Dose Findings Studies for Oncology Product Approval | RWE Shows that Short-Course Antibiotic Treatment is Better and Safer)

Newsletter - November 4, 2021 (Did Biogen Bribe Doctors or Play it Fairly? | Who’s Responsible for Food Safety: FDA, CDC or USDA?)

Newsletter - October 28, 2021 (Covid Vaccines Stole the Limelight from Therapies, it Seems. | 10 Principles for Machine Learning or AI Medical Devices from FDA)

Newsletter - October 21, 2021 (Real World Data for Animal Drugs, Too: New FDA Guidance Provides Tips | Are the Digital Medicine Products Moving Too Fast?)  

Newsletter - October 14, 2021 (FDA Eases Compounding Rules for Hospitals: Ever So Slightly but Significantly | ICH Releases Guidance on QbD Approach for Clinical Development Plans)  

Newsletter - October 7, 2021 (FDA’s Final Rule for De Novo Classification: Mostly Unchanged Process | FDA’s Tip on Communicating Cybersecurity Issues to Patients: Keep it Simple)

Newsletter - September 30, 2021 (FDA’s Guidance Describes the Subjectiveness of Benefit-Risk Assessments | Fully Electronic 510k Applications are Coming Soon)

Newsletter - September 23, 2021 (FDA’s Publication Highlights How to Use/Not Use Precedent Information | Paying Participants Helps with Recruitment for Low-Risk but Not The High-Risk Clinical Trials)

Newsletter - September 16, 2021 (ALS Drug Developer Cashes In on FDA’s Precedence in Alzheimer’s Disease | Biodistribution Studies for Genetic Therapy Products Explained by FDA)

Newsletter - September 9, 2021 (Is It a Drug, Food, or a Medical Food? FDA’s Clarifies Regulatory Semantics | FDA Describes the Process to Develop New Antimicrobial Agents for Food)

Newsletter - September 2, 2021 (FDA: No Need to Re-Monitor Remote Clinical Trials | FDA Start Online 510K-Review Tracker)

Newsletter - August 26, 2021 (Will Vaccine Approval Spur Off-Label Vaccination of Young Children | Accelerate Approval Pathway Does Not Need Reform, But Enforcement and Education)

Newsletter - August 19, 2021 (The Pandemic Changed Clinical Trials for Good | Is CBD a Drug or a Supplement? FDA Confuses Again.)

Newsletter - August 12, 2021 (Good Quality Real World Evidence is Hard to Come by | Vaccine Misinformation Highlights the Limits of FDA’s Powers)

Newsletter - August 5, 2021 (Is FDA’s Accelerated Approval Pathway in Danger of Being Scrapped, Was FDA Short-Staffed to Handle the Pandemic)

​Newsletter - July 29, 2021 (FDA’s First Interchangeable Biosimilar: Floodgate for Others? | Is FDA Taking Too Long to Approve the Covid Vaccines?)

Newsletter - July 22, 2021 (FDA’s Decision-Making Process is Immune to Buyer’s Remorse | FDA Would Like Inclusion of Pregnant Women in Clinical Research: Easier Said Than Done)

Newsletter - July 15, 2021 (FDA’s Aduhelm Decision is Permanent, Aduhlem will Not be an Exception | FDA Cannot Regulate Off-Label Use by Physicians: Decisive Court Decision)

​Newsletter - July 1, 2021 (Has FDA Been Corrupted? Tough Questions, Touchy Answers | PROs Have a Bigger Impact on FDA Decisions When Used as Primary Endpoints)

​Newsletter - June 24, 2021 (Second Tier Covid Vaccines Struggle: With Good or Bad Results | Fraudulent Academic Research Sinks Company; is it another Theranos?)

Newsletter - June 17, 2021 (The Biogen Decision Begs a Question: Do We Need FDA Advisory Committees? | “It's All In The Name”: How Titles of Publications Deceive Media.)

Newsletter - June 11, 2021 (FDA Finally Announces it is Clamping Down on Illegal Stem Cell Clinics | Biogen’s Accelerated Approval for its Alzheimer’s Drug: Controversial but Routine)

Newsletter - June 3, 2021 (Is FDA Turning Into a Virtual Organization For Good? It Seems Like It | FDA May Be Considering Ending In-Person Meetings with Sponsors)

Newsletter - May 27, 2021 (How Did South Korea Dealt Better With the Pandemic Than the US? Testing | Compliance and Data Integrity Issues with Remote Clinical Trials)

Newsletter - May 20, 2021 (FDA’s Four Possible Outcomes for No-PAIs Provide Strategic Openings | Covid EUA Holders: Are You Ready for Life After the Pandemic?)

Newsletter - May 13, 2021 (“Why EUA, Why Not Approval?” EUAs Fuel Vaccine Hesitancy | You Can Go to Jail for Lying to the FDA (Just in Case, You Did Not Already Know)

Newsletter - May 6, 2021 (FDA’s Auditing Resources Are Mostly Spent for Food Facilities, Not Drugs | How Much to Pay the Patients to Participate in Clinical Trials in the Pandemic)

Newsletter - April 29, 2021 (FDA Starts Enforcing Clinicaltrial.gov Law | FDA to Stem Cell Clinics: File an IND by June 1, or Close Business)

Newsletter - April 22, 2021 (Emergent’s FDA Audit Indicates Poor Vendor Validation by J & J | FDA To Limit Interstate Distribution of Compounded Drugs)

Newsletter - April 15, 2021 (FDA’s Guidance for Remote Audits: Good Intentions, Bad Perceptions | Its Time To Restart Clinical Trials in the US.)

Newsletter - April 8, 2021 (Are FDA’s In-Person Meetings Coming Back in the Fall | How Many Covid Vaccines Do We Need? Fate of Tier 2 Vaccines Seems Grim.)

Newsletter - April 1, 2021 (Do FDA’s Procedures make it Easier to Cover-up Negative Audit Findings | FDA’s Internal Processes for Handling Whistleblower Complaints Unmasked)

Newsletter - March 25, 2021 (More Regulation is Better for Certain Medical Devices: Industry Tells FDA | FDA’s Tango with the EUAs Exposed an Agency Disconnected from the Real World)

Newsletter - March 18, 2021 (Lab Supplies Still in Acute Shortage Due to the Pandemic | Do We Really Need FDA’s Pre-Approval Inspections? FDA’s Own Data Say, No.)

Newsletter - March 11, 2021 (The Pandemic is Coming to an End, and so are the EUAs | What is the Future of Covid Vaccines?)

Newsletter - March 4, 2021 (Too Many Poorly Designed Trials Led to the Lag in Covid Therapeutics: FDA | FDA “Requests” Fraudsters to Stop Making Fake Certificates)

Newsletter - February 25, 2021 (Doubting the Placebo in a Placebo-Controlled Study | Cancer Clinical Trials are The Worst Victim of the Pandemic)

Newsletter - February 18, 2021 (FDA Points at the Disconnect in What it Tells Companies and What They Disclose | Plavix Case: Deceptive Marketing or Regulatory Non-Compliance)

Newsletter - February 11, 2021 (Janet Woodcock, Tom Brady and Joe Biden: Leadership in 2021 | New EU Rule for Human Rights and Environment Abuse in Pharma Supply Chain)

Newsletter - February 4, 2021 (FDA’s Between a Rock and a Hard Place for its GMP Inspections | Stop Asking the FDA for Covid Vaccine Supply)

Newsletter - January 28, 2021 (Fate of Other Covid Vaccines? Where Regulations and Healthcare Collide | Could Social Media Have Prevented the Pandemic? A Reports Says Possibly.)
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Newsletter - January 21, 2021 (New Administration = New FDA? Not So much | Oncology and Regenerative Medicine Products, and the Biden Administration)

​Newsletter - January 14, 2021 (Global Regulatory Dilemma Due to the Less Effective Chinese Vaccine | Impact of Last Minute Rules for FDA and HHS by Trump Administration)

​Newsletter - January 7, 2021 (FDA Issues Year-End Warning Letters to CBD Product Manufacturers, Again | FDA Raises Important Confidentiality Warning in a New Guidance Document)  

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VIDEOS

Please CLICK HERE to watch the interview videos of Dr. Mukesh Kumar on various regulatory topics.

Past News

Please click below web links to read news blogs of respective years.
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FDAMap News Archive 2020

FDAMap News Archive 2019

FDAMap News Archive 2018

FDAMap News Archive 2017

FDAMap News Archive 2016

FDAMap News Archive 2015