FDAMap News 2018

Newsletter - December 13, 2018 (FDA Tries to Regulate LDTs.. Again! FDA Guidance on Data Integrity: A Must Read for All GMP Facilities)

Newsletter - December 6, 2018 (FDA Implements NIPP to Sterile Injectables GMP Inspections: Other to Follow | GCP Training is Not Enough to Qualify Investigators: Tips for Sponsors from CTTI)

Newsletter - November 29, 2018 (Gene Edited Babies and FDA: Can You Tailor An Embryo in the US? | Amazon, and Other Big Data Companies Move to Sell Health Related Datal)

Newsletter - November 15, 2018 (In the Age of RTT, FDA Struggles to Keep Its Compassionate Use Program Alive | Amarin Struggles Show Why Choice of The Right Placebo is Critical)

Newsletter - November 8, 2018 (Contaminated Water Lead to E. Coli in Lettuce, FDA Investigation Found | Is FDA Secretly Reducing the Number of Its Guidance Documents?)

Newsletter - October 25, 2018 (FTC Steps in Where FDA Won’t: Regulation of Stem Cell Clinics by FTC | FDA-MHRA GCP Workshop Highlights Key Trends in Data Integrity Issues)

Newsletter - October 18, 2018 (FDA’s Guidance on Successful Development of Rare Disease Products, Certain Classes of Dietary Supplements Contain Drugs More Often Than Others)

Newsletter - October 11, 2018 (Survey Shows Close Collaboration in Industry-Funded Academic Trials, If Even Doctors Can’t Read Diagnostics Well, How Can Patients)

Newsletter - October 4, 2018 (FDA Prioritizes Digital Health for 2019, FDA Expands the Special 510k Process)

Newsletter - September 27, 2018 (FDA Is “Writing Off” PDUFA Meetings Via “Written Response Only” Loophole, Monetary Fines for Failing to Post Results on Clinicaltrials.gov)

Newsletter - September 20, 2018 (FDA Releases New Educational Material for Opioid Prescribers, Is FDA Push for Restrictions on e-Cigarettes Based on Flawed Science and Hype)

Newsletter - September 13, 2018 (No More Paper: All Medical Device Submission to FDA to be Electronic Only, OIG Tells FDA to Make Cybersecurity Concerns a Criterion for RTF)

Newsletter - September 6, 2018 (FDA Describes How it Selects Manufacturing Sites for Inspections​, FDA Expands the Parallel Review Program to Private Payors to Expedite Device Access)

Newsletter - August 30, 2018 (FDA’s Warns Online Pharmacies Selling Drugs Illegally Highlighting Challenges to Enforcement, FDA Initiative for Innovative Clinical Trial Designs to Expedite Product Approval)

Newsletter - August 23, 2018 (FDA: Use Alternate Strategies to Include Data From “Interesting” Patients in Clinical Trials, What’s All the Fuss About Number of 483s Issued in India and China?)

Newsletter - August 16, 2018 - August 16, 2018 (Mobile technologies in Clinical Trials: Detailed Roadmap from CTTI and FDA, FDA Approval of a Contraceptive Mobile App Shows Why It is Not Worth it)

Newsletter - August 2, 2018 (FDA Commissioner’s Tweetorials: The New Age of FDA Advice Via Tweets, Got Milk! Not if You Ask FDA)

Newsletter - July 26, 2018 (FDA Provides a Path to Use RWE For New Approvals: Highlights Challenges With Doing the Same, FDA Proposes Special Meetings to Discuss New Surrogate Endpoints)

Newsletter - July 19, 2018 (Conflict of Interest at FDA: Is it Real or Hype, Breakthrough Therapies Do Not Lead to Unsafe Drugs.)

Newsletter - July 5 2018 (Highlight Is FDA Recall Process Too Slow To Protect Consumers? Victims Blame FDA, FDA is Hiring A Lot of New Reviewers and Managers at Higher Salaries)

 Newsletter - June 28, 2018 (Highlight: Right-To-Try Will Kill Clinical Trials in High-Risk Patients, FDA’s New Pre-Pre-IND Process Allow Early Strategic Discussions for Biologics)

 Newsletter - June 21, 2018 (Highlight: FDA Allows Off-Label Promotion, Sort of, FDA Fee Waivers, Refunds and Reductions: Apply within 4-6 months of Need)

Newsletter - June 7, 2018 (Highlight: What Does a “Modernized” FDA Mean for Drug Industry, FDA Gives Company Cease and Desist Letter for Online Sale of Prescription Diagnostics)

Newsletter - May 31, 2018 (Highlight: Survey Shows Multivitamins Do Not Reduce Mortality but Does it Matter, In the Age of Personalized Medicine and Right to Try-Have Big Clinical Trials Become Obsolete)

Newsletter - May 24, 2018 (Highlight: Impossible Burger Shows How Impossible FDA’s Job Is When It Comes to Food, Right-To-Try Does Not Change Drug Company-Patient Interactions for Test Drugs)

Newsletter - May 18, 2018 (Highlight: No You Cannot Manufacture Pesticides and Drugs with the Same Machine, FDA Wants IRBs to Write Better SOPs)

Newsletter - May 10, 2018 (Highlight: FDA Files its First Injunctions against More Than 100 Stem Cell Clinics, FDA Provides Additional Guidance for Digital Health Products)

 Newsletter - May 4, 2018 (Highlight: No More Paper: FDA to Accept Only Electronic Documents for Most Submissions, FDA Allows Health Claims for Food Labeling and Marketing)

Newsletter - April 26, 2018 (Highlight: FDA Gives and FDA Taketh Back: Rescinding Breakthrough Designation, Senator’s 7 Questions to FDA about Stem Cell Clinics: Politics of Stem Cells)

Newsletter - April 19, 2018 (Highlight: Lowering Regulatory Standards Encourages Unproven Stem Cell Therapies, FDA Reverses Its Decision to Show Anything is Possible with Negotiation)

Newsletter - April 12, 2018 (Highlight: FDA Redefines Expectations for Clinical Trials in Children and Pregnant Women, FDA Expands Abbreviated 510k Process for Moderate Risk Devices)

Newsletter - April 5, 2018 (Highlight: FDA’s Review Process Shows Preferential Treatment of NMEs for Unmet Medical Needs, FDA’s Pre-Approval Inspection Matrices Show Interesting Trends)

Newsletter - March 29, 2018 (Highlight: Limitations of Sunshine: Disclosure Laws Do Little to Discourage Undesirable Activities, FDA Strongly Opposes Compounding Drugs for Financial Reasons)

Newsletter - March 22, 2018 (Highlight: FDA Posts Full Clinical Study Report for NDA for Novel Products, How Binding Are the FDA Guidance Documents? DOJ Says, Not Much)

Newsletter - March 15, 2018 (Highlight: “Fake News” on Clinicaltrials.gov? Investigations Expose Loop Holes, Why Drug Price Control Proponents Should Thank Martin Shkreli)

Newsletter - March 8, 2018 (Highlight: Lessons from a “War” Between a Compounding Pharmacy and FDA, Federal Right-To-Try Law Gains Strength: Hope or False Hype)

Newsletter - March 1, 2018 (Highlight: FDA’s Modernized Review Process: Improved Guidance Documents, FDA Amends GCP Guideline to Emphasize Quality Responsibilities)

Newsletter - February 22, 2018 (Highlight: FDA Expects GCP Compliance from all Medical Device Trials, FDA Explains the Pre-RFD Process for Combination Product Designation)

Newsletter - February 15, 2018 (Highlight:Ethics of Placebo-Controlled Studies: Pediatric Study Challenged, FDA’s Wish-List for 2018 Includes Ambitious and Achievable Goals)

Newsletter - February 8, 2018 (Highlight:Cell Phone Radiation and Cancer Puts FDA and NTP at Odds; Somewhat, Poor Regulation of Antibiotics in India Creates Global Nightmare)

Newsletter - February 1, 2018 (Highlight: Can You Sue FDA for Negative Audit Findings? Indian Company Tests US Legal System, Some States to Allow Off Label Promotion of Drugs: Headache for FDA?)

Newsletter - January 25, 2018 (Highlight: Government Shutdown and FDA: Should Pharma Care or Not, FDA Explains its Wish List for Quality Overall Summary in NDAs and BLAs)

Newsletter - January 18, 2018 (Highlight: New FDA Rule for Labeling Requirements for Prescription Drugs, FDA Doubles Down on the Least Burdensome Approach to Approval)

Newsletter - January 11, 2018 (Highlight: The Most Common FDA Audit Findings From 2017, How to Meet FDA: New Guidance Formalizes Well Know Common Sense)