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Newsletter Archive 2018

Newsletter, January 11, 2018

The Most Common FDA Audit Findings From 2017

How to Meet FDA: New Guidance Formalizes Well Know Common Sense

Newsletter, January 18, 2018

New FDA Rule for Labeling Requirements for Prescription Drugs

FDA Doubles Down on the Least Burdensome Approach to Approval

Newsletter, February 1, 2018

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, February 8, 2018

Cell Phone Radiation and Cancer Puts FDA and NTP at Odds; Somewhat

Poor Regulation of Antibiotics in India Creates Global Nightmare

Newsletter, February 15, 2018

Ethics of Placebo-Controlled Studies: Pediatric Study Challenged

FDA’s Wish-List for 2018 Includes Ambitious and Achievable Goals

Newsletter, February 22, 2018

FDA Expects GCP Compliance from all Medical Device Trials

FDA Explains the Pre-RFD Process for Combination Product Designation

Newsletter, March 1, 2018

FDA’s Modernized Review Process: Improved Guidance Documents 

FDA Amends GCP Guideline to Emphasize Quality Responsibilities

Newsletter, March 8, 2018

Lessons From A “War” Between A Compounding Pharmacy and FDA

Federal Right-To-Try Law Gains Strength: Hope or False Hype

Newsletter, March 15, 2018

“Fake News” on Clinicaltrials.gov? Investigations Expose Loop Holes

Why Drug Price Control Proponents Should Thank Martin Shkreli

Newsletter, March 22, 2018

FDA Posts Full Clinical Study Report for NDA for Novel Products

How Binding Are the FDA Guidance Documents? DOJ Says, Not Much

Newsletter, March 29, 2018

Limitations of Sunshine: Disclosure Laws Do Little to Discourage Undesirable Activities

FDA Strongly Opposes Compounding Drugs for Financial Reasons

Newsletter, April 5, 2018

FDA’s Review Process Shows Preferential Treatment of NMEs for Unmet Medical Needs

FDA’s Pre-Approval Inspection Matrices Show Interesting Trends

Newsletter, April 12, 2018

FDA Redefines Expectations for Clinical Trials in Children and Pregnant Women

FDA Expands Abbreviated 510k Process for Moderate Risk Devices

Newsletter, April 19, 2018

Lowering Regulatory Standards Encourages Unproven Stem Cell Therapies

FDA Reverses Its Decision to Show Anything is Possible with Negotiation

Newsletter, April 26, 2018

FDA Gives and FDA Taketh Back: Rescinding Breakthrough Designation

Senator’s 7 Questions to FDA About Stem Cell Clinics: Politics of Stem Cells

Newsletter, May 3, 2018

No More Paper: FDA to Accept Only Electronic Documents for Most Submissions

FDA Allows Health Claims for Food Labeling and Marketing

Newsletter, May 10, 2018

FDA Files its First Injunctions Against More Than 100 Stem Cell Clinics

FDA Provides Additional Guidance for Digital Health Products

Newsletter, May 17, 2018

No You Cannot Manufacture Pesticides and Drugs With the Same Machine.

FDA Wants IRBs to Write Better SOPs

Newsletter, May 24, 2018

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 31, 2018

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, June 7, 2018

What Does a “Modernized” FDA Mean for Drug Industry?

FDA Gives Company Cease and Desist Letter for Online Sale of Prescription Diagnostics

Newsletter, June 21, 2018

FDA Allows Off-Label Promotion, Sort of.

FDA Fee Waivers, Refunds and Reductions: Apply within 4-6 months of Need

Newsletter, June 28, 2018

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, July 5, 2018

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, July 19, 2018

Conflict of Interest at FDA: Is it Real or Hype?

Breakthrough Therapies Do Not Lead to Unsafe Drugs.

Newsletter, July 26, 2018

FDA’s 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, August 2, 2018

FDA Commissioner’s Tweetorials: The New Age of FDA Advice Via Tweets

Got Milk! Not if You Ask FDA.

Newsletter, 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 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 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, 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, 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 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 27, 2018

FDA Is “Writing Off” PDUFA Meetings Via “Written Response Only” Loophole

Monetary Fines for Failing to Post Results on Clinicaltrials.gov

Newsletter, October 4, 2018

FDA Prioritizes Digital Health for 2019

FDA Expands the Special 510k Process

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 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 24, 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, 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, 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 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 Data

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, December 13, 2018

FDA Tries to Regulate LDTs.. Again!

FDA Guidance on Data Integrity: A Must Read for All GMP Facilities

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