FDAMap News 2016

Newsletter - December 22, 2016 (Highlight: “Should I Throw That Milk Away”, “May be Not”, says USDA, Almost All Clinical Trials Must be Registered with Clinicaltrials.gov)

Newsletter - December 15, 2016 (Highlight: Real World Data For 505(b)(2) Development Programs, Electronic Informed Consent Gets More Guidance from FDA)

Newsletter - December 8, 2016 (Highlight: Will the New Law Boost Stem Cell Products and Other Regenerative Therapies, Adverse Events for Food and Cosmetics)

Newsletter - December 1, 2016 (Highlight: FDA to Provide Special Help to Manufacturers with New Technology, Pharma’s Wish List for President Trump: Flexible Regulation)

Newsletter - November 17, 2016 (Highlight: FDA’s Policy for Off-Label Promotion Takes a Deep Dive Public Discussion, Predicting “Good” Employees in Technology Companies: Hiring Advise)

Newsletter - November 10, 2016 (Highlight: Trump Effect on FDA Regulated Industry, Twitter Based Scientific Research)

Newsletter - November 3, 2016 (Highlight: Multinational Expedited Approval Pathways, Biased Clinical Trial Results)

Newsletter - October 27, 2016 (Highlight: FDA Makes it Easy for Whistleblowers to Report Misconduct by Medical Device Companies, FDA is Curious about Future Technologies)

Newsletter - October 20, 2016 (Highlight: Developing Rare Disease Products: Lessons from Serepta and Biomarin, Does Screening Tests Save Life? Ben Stiller Creates Prostate News)

Newsletter - October 13, 2016 (Highlight: Are Priority Review Vouchers Really Worth the Hype? May be Not, FDA New Inspection Protocol Project: New Improved Way for GMP Audit)

Newsletter - October 6, 2016 (Highlight: Most Ex-FDA Reviewers Work for the Regulated Industry and That’s A Good Thing, Is FDA “Over-Regulating” Some Low-Risk Products?).

Newsletter - September 29, 2016 (Highlight: Should FDA Accept Data From Clinical Trials Conducted in China, Companies Do Not Publish All Adverse Events from Sponsored Clinical Trials)

Newsletter - September 22, 2016 (Highlight: 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 15, 2016 (Highlight: FDA Announces Plan to Release About 100 New Guidance Documents, Are E-Cigarettes Good Smoking Cessation Products? Depends on Who You Ask.)

Newsletter - September 8, 2016 (Highlight: Five Lessons from Hillary’s Email Saga: Why Part 11 Should be a Universal Best Practice, Is Direct-to-Consumer Advertisement Misleading?)

Newsletter - September 1, 2016 (Highlight: Does it Matter if Your CRO is Big or Small | Another Drug Price Hike, Another Hollow Debate: Mylan’s EpiPen)

Newsletter - August 25, 2016 (Highlight: 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 - August 18, 2016 (Highlight: New RFD Process: FDA’s Tacit Acknowledgment of Flaws in the System, FDA’s New Rules for GRAS Provide Clarity on what is Safe Food)

Newsletter - August 11, 2016 (Highlight: Spiderman is Real! Well.. May be Soon, Clinical Trials in India Still at Peril Due to Regulatory Burdens)

Newsletter - August 4, 2016 (Highlight: Want to Make Wearable Devices More Appealing - Register with FDA, If the Drug Works, It’s Ok Not Knowing the Mechanism of Action)

Newsletter - July 28, 2016 (Highlight: FDA Approval Rate Shows Indian GMP Sites Are in Good Compliance, Email Leaks, Politics and FDA-Regulated Industry)

Newsletter - July 21, 2016 (Highlight: FDA Clarifies: NIH’s Single IRB Policy to Impact Non-NIH Funded Clinical Trials Too, Manufacturers of Biologics to Increasingly Use Single-Use Technologies)

Newsletter - July 14, 2016 (Highlight: FDA Clarifies: You Cannot Compound Approved Drugs, What Sunshine Act? Are Payments to Doctors by Companies Undeterred?)

Newsletter - July 7, 2016 (Highlight: FDA User Fee for OTC Drugs: Beware of What You Wish For, Gifts to FDA: FDA’s Strangest Guidance Document)

 Newsletter - June 30, 2016 (Highlight: 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 - June 23, 2016 (Highlight: How Effective is FDA’s Push for Diversity in Clinical Trials, Can Doctors be Bought with a Slice of Pizza)

Newsletter - June 16, 2016 (Highlight: FDA-Regulated Industry May Have Found the Best Example in Theranos to Educate Public, Patients Prefer Their Doctors to be Dressed Professionally)

Newsletter - June 9, 2016 (Highlight: 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 1, 2016 (Highlight: 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 - May 26, 2016 (Highlight: Clinical Trial Recruitment Planning - Tips and Tools, Digital Tools in Clinical Trials Increase Trial Efficiency and Reduce Errors)

Newsletter - May 19, 2016 (Highlight: Opioid Regulations on Steroids: No Pun Intended, Clinical Trial Results and Clinical Trial Protocol Mismatch)

Newsletter - May 12, 2016 (Highlight: Poorly structured survey misrepresents FDA approval process, Company Wins “Healthy” Label from FDA)

Newsletter - May 05, 2016 (Highlight: Data Integrity and Theranos: Lessons from the Extreme Non-Compliance, Retracted Research Articles and Research Integrity)

Newsletter - April 28, 2016 (Highlight: Use of FDA’s Expedited Approval Programs: How Fast is Too Fast, Does Passionate CEO and Illegal Clinical Research Lead to Good Science?)

Newsletter - April 21, 2016 (Highlight: How to Deal with Data Integrity Woes: New FDA’s Guidance to Help, Dietary Supplements with Risky Ingredients: Aided by Powerless FDA?)

Newsletter - April 14, 2016 (Highlight: Multiple Efforts to Increase Recruitment of Subjects in Clinical Trials, Do Physicians Lack Understanding of FDA Approval Processes)

Newsletter - April 8, 2016 (Highlight: HCT/Ps Get Support from US Congress, US Government to Help Create Manufacturing Processes for Cell-Based Medicine)

Newsletter - March 31, 2016 (Highlight: Efforts to Control Opiate Abuse shift to Doctors Who Prescribe Painkillers, Life-Style Genetic Tests Have Limited Clinical Use)

Newsletter - March 24, 2016 (Highlight: Opiate Regulation Gets a Major Makeover, Breakthrough Designation Speeds Up Approval but Strains FDA's Resources)

Newsletter - March 17, 2016 (Highlight: 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 10, 2016 (Highlight:  Breakthrough Therapies in Europe: EMA Launches PRIME, Tweeting to Recruiting Patients: Social Media in Clinical Trials)

Newsletter - March 03, 2016 (Highlight:  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 - February 25, 2016 (Highlight:  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 - February 18, 2016 (Highlight: First Biosimilar with Extrapolation: Interchangeability, Dietary Supplements with Risky Ingredients: Aided by Powerless FDA)

Newsletter - February 11, 2016 (Highlight: Food GMP and Chipotle: PR Stunt or Real Concern, GMP Sites in China and India: A Comparison)

Newsletter - February 04, 2016 (Highlight: Are GMP Sites in China Better Than Those in India, FDA Drug and Biologic Approval at All Time High)

Newsletter - January 28, 2016 (Highlight: Drug Pricing Debates Get Politicized in the Wrong Way, Journals to Require Clinical Data Sharing for Publishing Articles)
 
Newsletter - January 21, 2016 (Highlight: 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 14, 2016 (Highlight: FDA Launches Multiple Initiatives for Patient-Focused Clinical Trials, About 20% of Cancer Clinical Trials Fail due to Low Patient Recruitment)