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Newsletter Archive 2016

​Newsletter, January 14, 2016

FDA Launches Multiple Initiatives for Patient-Focused Clinical Trials

About 20% of Cancer Clinical Trials Fail Due to Low Patient Recruitment

​Newsletter, January 21, 2016

Remote- and Risk-Based Monitoring Reduce the Need for CRAs in Clinical Trials

Most Clinical Trials Do Not Report Results on Clinicaltrials.gov

Research Productivity: Who Discovers More, Academia or Industry?

​Newsletter, January 28, 2016

Drug Pricing Debates Get Politicised in the wrong way

Journals to Require Clinical Trial Data Sharing for Publishing Articles

​Newsletter, February 4, 2016

Are GMP Sites in China Better Than Those in India?

FDA Drug and Biologic Approval at All Time High

​Newsletter, February 11, 2016

Food GMP and Chipotle: PR Stunt or Real Concern

GMP Sites in China and India: A Comparison

​Newsletter, February 18, 2016

First Biosimilar with Extrapolation: Interchangeability is Next

Dietary Supplements with Risky Ingredients: Aided by Powerless FDA?

Newsletter, February 25, 2016

Use FDA’s Processes to Speed US Patient Access to Cuban Lung Cancer Vaccine

GAO Questions FDA’s Post-Marketing Oversight for Drugs Approved via Expedited Programs

Newsletter, March 3, 2016

Priority Review Vouchers and FDA: Agency Complains of Increased Work

Use FDA’s Processes to Speed US Patient Access to Cuban Lung Cancer Vaccine

Newsletter, March 10, 2016

Breakthrough Therapies in Europe: EMA Launches PRIME

Tweeting to Recruit Patients: Social Media in Clinical Trials

Newsletter, March 17, 2016

Honest Troubles: Raw Material Risk Management in Focus

Attempt to Sue Indian Drug Regulators in Indian Supreme Court Fails but Provides New fodder to Critiques

Newsletter, March 24, 2016

Opiate Regulation Gets a Major Makeover

Breakthrough Designation Speeds Up Approval but Strains FDA’s Resources

Newsletter, March 31, 2016

Efforts to Control Opiate Abuse shift to Doctors Who Prescribe Painkillers

Life-Style Genetic Tests Have Limited Clinical Use

Newsletter, April 8, 2016

HCT/Ps Get Support from Congress but Benefits are Limited

US Government to Help Create Manufacturing Processes for Cell-Based Medicine

Newsletter, April 14, 2016

Multiple Efforts to Increase Recruitment of Subjects in Clinical Trials

Do Physicians Lack Understanding of FDA Approval Processes?

Newsletter, April 21, 2016

How to Deal with Data Integrity Woes: New FDA’s Guidance to Help

Dietary Supplements with Risky Ingredients: Aided by Powerless FDA?

Newsletter, April 28, 2016

Use of FDA’s Expedited Approval Programs: How Fast is Too Fast

Does Passionate CEO and Illegal Clinical Research Lead to Good Science?

Newsletter, May 5, 2016

Data Integrity and Theranos: Lessons from the Extreme Non-Compliance

Retracted Research Articles and Research Integrity

Newsletter, May 12, 2016

Poorly Structured Survey Misrepresents FDA Approval Process

Company Wins "Healthy" Label from FDA

Newsletter, May 19, 2016

Opioid Regulations on Steroids: No Pun Intended

Clinical Trial Results and Clinical Trial Protocol Mismatch

Newsletter, May 26, 2016

Clinical Trial Recruitment Planning: FDA and Others Provide Tips and Tools

Digital Tools in Clinical Trials Increase Trial Efficiency and Reduce Errors

Newsletter, June 1, 2016

Drug Approvals in EU and US: Harmonization of Rules at FDA and EMA

Is the Use of Wearable Devices in Clinical Trials Over-Hyped?

Newsletter, June 9, 2016

FDA Expects Patients to Play a Bigger Role in Drug Development

Drug Approvals in EU and US: Harmonization of Rules at FDA and EMA

Newsletter, June 16, 2016

FDA-Regulated Industry May Have Found the Best Example in Theranos to Educate Public

Patients Prefer Their Doctors to be Dressed Professionally

Newsletter, June 23, 2016

How Effective is FDA's Push for Diversity in Clinical Trials?

Can Doctors be Bought with a Slice of Pizza?

Newsletter, June 30, 2016

Brexit Will Not Have a Major Affect on Drug Approvals in UK and Europe

Cancer Drug Developers Get More Help in FDA's New "Oncology Center of Excellence"

Newsletter, July 7, 2016

FDA User Fee for OTC Drugs: Beware of What You Wish For.

Gifts to FDA: FDA's Strangest Guidance Document

Newsletter, July 14, 2016

FDA Clarifies: You Cannot Compound Approved Drugs

What Sunshine Act? Are Pa ments to Doctors b Companies Undeterred?

Newsletter, July 21, 2016

NIH's Single IRB Policy to Impact Non-NIH Funded Clinical Trials Too

Manufacturers of Biologics to Increasingly Use Single-Use Technologies

Newsletter, July 28, 2016

FDA Approval Rate Shows Indian CMP Sites Are in Good Compliance

Email Leaks, Politics and FDA-Regulated Industry

Newsletter, August 4, 2016

Want to Make Wearable Devices More Appealing? Register with FDA

If the Drug Works, It's 0k Not Knowing the Mechanism of Action

Newsletter, August 11, 2016

Spiderman is Real! Well.. May be Soon

Clinical Trials in India Still at Peril Due to Regulatory Burdens

Newsletter, August 18, 2016

New RFD Process: FDA's Tacit Acknowledgment of Flaws in the System

FDA's New Rules for CRAS Provide Clarity on what is Safe Food

Newsletter, August 25, 2016

Clinical Trials in Pets: Less Expensive and More Promising

FDA's Updated GLP Rules Will Disallow Most Academic Non-Clinical Studies from Regulatory Applications

Newsletter, September 1, 2016

Does it Matter if Your CRO is Big or Small?

Another Drug Price Hike, Another Hollow Debate: Mylan's EpiPen

Newsletter, September 8, 2016

Five Lessons from Hillary's Email Saga: Why Part 11 Should be a Universal Best Practice

Is Direct-to-consumer Advertisement Misleading?

Newsletter, September 15, 2016

FDA Announces Plan to Release About 100 New Guidance Documents

Are E-Cigarettes Good Smoking Cessation Products? Depends on Who You Ask.

Newsletter, September 22, 2016

Strict Food Quality Rules Come into Effect This Week: FSMA Compliance

Final Rule for Mandatory Reporting of Clinical Trials Results on Clinicaltrials.gov: No Excuses

Newsletter, September 29, 2016

Should FDA Accept Data From Clinical Trials Conducted in China?

Companies Do Not Publish All Adverse Events from Sponsored Clinical Trials

Newsletter, October 6, 2016

Most Ex-FDA Reviewers Work for the Regulated Industry and That's A Good Thing

Is FDA "Over-Regulating" Some Low-Risk Products?

Newsletter, October 13, 2016

Are Priority Review Vouchers Really Worth the Hype? May be Not.

FDA New Inspection Protocol Project: New Improved Way for CMP Audit

Newsletter, October 20, 2016

Developing Rare Disease Products: Lessons from Serepta and Biomarin

Does Screening Tests Save Life? Ben Stiller Creates Prostate News

Newsletter, October 27, 2016

FDA Makes it Easy for Whistleblowers to Report Misconduct by Medical Device Companies

FDA is Curious about Future Technologies

Newsletter, November 3, 2016

Multinational Expedited Approval Pathways

Biased Clinical Trial Results

Newsletter, November 10, 2016

Trump Effect on FDA Regulated Industry

Twitter Based Scientific Research

Newsletter, December 1, 2016

FDA to Provide Special Help to Manufacturers with New Technology

Pharma’s Wish List for President Trump: Flexible Regulation

Newsletter, December 8, 2016

Will the New Law Boost Stem Cell Products and Other Regenerative Therapies?

Adverse Events for Food and Cosmetics

Newsletter, December 15, 2016

Real World Data For 505(b)(2) Development Programs

Electronic Informed Consent Gets More Guidance from FDA

Newsletter, December 22, 2016

“Should I Throw That Milk Away”, “May be Not”, says USDA

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