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Newsletter Archive 2015

​Newsletter, May 14, 2015

Blue Bell listeria outbreak exposes limitation of FDA’s food inspection program

FDA wants to further regulate hand cleaners used in hospitals

FDA increased GMP audits of generic drug facilities by 60%

​Newsletter, May 21, 2015

FDA Raises Concerns Regarding Security of Software Running Medical Devices

Another Off-Label Claim Dispute between Industry and FDA: Amarin’s Vascepa (Omega 3 Fatty Acid)

Unacceptable Reprocessing of Medical Devices: Case of Duodenoscopes

​Newsletter, May 28, 2015

FDA Explains Why Many Cancer Drugs Fail

Regulations on Fixed-Dose Combination and Co-Packaged Drug and/or Biological Products Simplified

Insurance Coverage of a New Medical Device is Not Guaranteed by FDA Approval: Acid-Reflux Device Refused Coverage

​Newsletter, June 4, 2015

US Congressman Challenges FDA’s Untitled Letters

FDA Wants to Study Personal and Social Aspects of Drug Ads

FDA to Require Mandatory Electronic Submission of Most Applications

​Newsletter, June 11, 2015

Female Viagra May Finally Get FDA Approval: Third Time is the Charm

NIH Drug Production Facility Found in Gross Violation of GMP

​Newsletter, June 11, 2015

Female Viagra May Finally Get FDA Approval: Third Time is the Charm

NIH Drug Production Facility Found in Gross Violation of GMP

FDA Advisory Committee Recommends Limited Approval of Two New Cholesterol Lowering Biotech Drugs with Reservation

​Newsletter, June 18, 2015

FDA Mistakenly Widened the Market for a Rare Sleep Disorder Drug: A Consumer Group

Supporters of Right-To-Try Legislation Sue FDA to Release Documents Related to Ebola Drug Use during Last Year’s Ebola Outbreak

​Newsletter, June 24, 2015

FDA Approves Brio Neurostimulation System, the Second Brain Implant that Brings Relief from Parkinson’s Symptoms

​Newsletter, June 26, 2015

FDA’s Announcement of Negative Audit Findings Lead to Similar Actions by Other Regulators

Google Changes SEM Policies for Drug Ads to Meet FDA Requirements

​Newsletter, July 2, 2015

The Breakthrough Designation Can be Withdrawn or Rescinded by FDA

FDA Inspectors = Sherlock Holmes: FDA Inspector to Find Major Issues with GMP Compliance by Paying Close Attention to Details

​Newsletter, July 9, 2015

Unblinded Studies are Biased Even if the Researchers are Well-Intentioned

US FDA and Interpol Seize 21 Million Fake Medicines Worth $81 Million in One Week of Joint Operation

​Newsletter, July 16, 2015

Should Prescription Drugs Cost be Controlled in the US?

SOP Deficiencies and Documentation Errors Dominate EMA GCP Audit Findings

Manufacturers of Biologics to Increasingly Use Single-Use Technologies

​Newsletter, July 23, 2015

EMA to Follow FDA-Like Practice to Advice on Post-Marketing Study Design

FDA Wants to Know Drug Side-Effects by Google Search

FDA Rapidly Updating its Policies to Regulate Medical Software to Match the Technological Realities

​Newsletter, July 30, 2015

High Levels of Drugs Found in Water Supplies World-Wide

Will Clinical Trial Data Sharing Hurt Innovation?

FDA Requires Drug Companies to Update Analytical Procedures as Part of Life-Cycle Management

​Newsletter, August 6, 2015

Abuse Deterrent Technology Comes of Age in Opioid Formulation

Medical Device Labeling in FDA’s Cross-Hair

Hacking into a Remote-Controlled Medical Device is Not Science Fiction Anymore

​Newsletter, August 13, 2015

Courts Goes Against FDA to Allow Off-Label Promotion… Again!

​Newsletter, August 17, 2015

GMP Issues for 3D Printed Pills Resolved But Is It Really a Big Deal?

The Promise of Bacteriophage Therapy Rekindled but Hurdles Remain

​Newsletter, August 20, 2015

Celebrity Endorsement and FDA: An Unwinnable Battle for the Agency

Female Viagra Marketing Set to Test Off-Label Sale Rules Post FDA Approval

Office of Generic Drugs Opens The Door a Bit to Get Timely ANDA Updates

​Newsletter, September 3, 2015

GCP Inspectors Need to be Highly Qualified, Says EMA

Electronic Informed Consent in Clinical Trials: Opportunity or Liability

​Newsletter, September 10, 2015

Should FDA Be More Flexible For Approval of Drugs For Severe Diseases?

Drug Industry Lobby Group Defends High Drug Prices

​Newsletter, September 17, 2015

Food Safety Comes to Fore with New FDA Rules for GMP

FDA Blocks Four New Cigarette Brands from the Makers of Camel®

FTC Wants FDA to Increase Regulation of Homeopathic Drugs

​Newsletter, September 24, 2015

CEO Jailed for Life in Food Contamination Case

One Bad Apple! Not Really. Price Gauging Puts Practice on Front Page

Doctor’s Role in Clinical Trial Quality Likely Takes Center Stage with the New FDA Commissioner

​Newsletter, October 1, 2015

FDA to Destroy Illegal Drugs Arriving in the US by Mail

Is FDA’s Expedited Approval Programs Leading to Bad Drugs

USP Revises Compounding Pharmacy Rule to Address Sterile Drugs

​Newsletter, October 8, 2015

Pharma Product Hopping and Product Evergreening in the Limelight Again

Updates to GCP and US Government Policies for Clinical Trial Patients

Lack of GMP Training is Expensive: Lessons from Compounding Pharmacies

​Newsletter, October 15, 2015

Herbal Supplements Linked to Thousands of ER Visits Each Year

My Girl likes Pink and My Boy Likes Blue: Study of Gender Differences in Clinical Trials

Most Cell lines Used in Testing May Be Incorrectly Identified

​Newsletter, October 23, 2015

Human Factors to Play a Bigger Role in FDA’s Decisions about Medical Devices

Genetic Tests: Two Companies Different Stories

​Newsletter, October 29, 2015

Are Indian Drug Manufacturers Really That Bad in GMP Compliance?

Compounding Expensive FDA-Approved Drugs to Reduce Price: Potential Challenge to the 505(b)(2) or Generic Pathway

​Newsletter, November 5, 2015

Tobacco Regulation on Steroids!! FDA Comes Down Hard on Tobacco Retailers

Want to Know What Trials Supported FDA Approval? Look No Further.

​Newsletter, November 12, 2015

GMP Compliance at Indian Drug Manufacturers Questioned by RAPS

Tobacco Regulation on Steroids!! FDA Comes Down Hard on Tobacco Retailers

​Newsletter, November 19, 2015

Is the FDA at Fault for Allowing Drugs Made in India Despite Multiple GMP Violations?

Clinical Trial Results Remain Under-Reported Publicly

​Newsletter, December 3, 2015

New Rules from Department of Justice to Target CEOs for Non-Compliance

FDA Slams Company for “Healthy” Label, Company Fights Back

FDA Encourages Resolving Disputes with Sponsors before Legal Actions

​Newsletter, December 10, 2015

FDA is Seriously Concerned about Lab Developed Tests and Wants to Regulate Them Strictly

Best Practices for Meetings with FDA: New Guidance, “Old” Information

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