Posted 02 September 2014 | By Alexander Gaffney, RAC,

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

This fall, regulatory professionals from across the globe will come together to learn, connect and share at the Regulatory Affairs Professionals Society’s 2014 RAPS: The Regulatory Convergence, 27 September-1 October, Austin, TX. Register here.

In Focus: US

In Focus: International

US: Pharmaceuticals and Biotechnology

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

US: Pharmaceuticals and Biotechnology: General

Which Countries Excel in Creating New Drugs? It’s Complicated (Xconomy)

Pricing is key for new heart drugs challenging cheap generics (Reuters)

Public Citizen Comes out Against TPP (Citizen)

US: Medical Devices

US: Dietary Supplements

FTC Wants Supplement Executives Jailed After Judge Imposes $40 Million in Sanctions (NPI)

NBTY sued over allegedly pumping up protein claims for whey product (NI-USA)

Regeneca Worldwide, a Division of Vivaceuticals, Inc Expands the Voluntarily Recall of Regeneslim Appetite Control Capsules Due to the Presence of DMAA that May Pose Possible Health Risk (FDA)

US: Assorted And Government

More Data to Be Kept from Doc Payments Database (ProPublica)

Upcoming Meetings

Ebola Outbreak

Europe

GE Healthcare Announces European Union Approval of VIZAMYL in Suspected Alzheimer’s Disease (Press)

European Medicines Agency updates guidance on European Union periodic-safety-update-report single assessment for nationally authorised medicines (EMA)

Germany’s IQWiG denies Astellas’ incontinence drug (PMLive)

Insufficient Postage Leads to Bust of Fake Drugs (AP)

EMA Hires New Comms Head (EMA)

Allergan Announces OZURDEX (dexamethasone 700 mcg intravitreal implant in applicator) Now Approved in the European Union for the Treatment of Diabetic Macular Edema (Press)

U.K. Cancer Drug Fund May Shift To ‘Coverage With Evidence Development’-Style Approach (Pink Sheet-$)

Claiming Pressure From European Regulators, Trial Leaders Cancel Press Conference (Forbes)

Numbers of clinical trials in Denmark have stabilized (Pharma Letter-$)

Sophia Genetics Becomes the First European Company to Obtain CE-IVD Mark for Clinical use of Next Generation Sequencing Bioinformatics Pipeline for Routine Genetic Testing (Press)

India

India To Exempt Certain Drugs From Trials (PharmAsia-$) (India Times)

With regulatory action on rise, pharma liability cover takes prominence (Business Standard)

'Patients back-out from trials fearing Audio/Video consent' (BioSpectrum)

59 new drug applications pending review at CDSCO (BioSpectrum)

Gardasil Studies in India Faulted for Improper Consent, Potential Side Effects (India Times)

Consecutive drug reactions: Doctors puzzle over why patients in 14 other hospitals were not hit by antibiotics (Times of India)

China

Fujian releases new policies to support pharmaceutical industry (Xiamen)

Survey: Pharmaceutical and Other Foreign Companies in China Feel 'Targeted' (AP)

Japan

Novartis fails to report side effects, fatality (PharmaGossip) (PharmAsiaNews-$) (AFP) (SCRIP-$)

Japan paves way for innovative home-grown drugs, devices (Clinica-$)

MHLW Planning Follow-up Survey On HPV Vaccine Side-Effects (PharmAsia-$)

Canada

Canada bans citronella-based bug spray (CBC)

Other International

Taiwanese urge for Orphan Drug Act (BioSpectrum)

Brazil plans shake-up of clinical trial approval process (SCRIP-$)

Nigeria: NAFDAC Raids Kano Markets, Seizes Fake Drugs Worth Millions of Naira (AllAfrica)

Mexico first country to launch Novo Nordisk’s Ryzodeg (Pharma Letter-$) (PMLive)

Clinical Trials

Clinical trials: the technology catching cheating volunteers (Outsourcing Pharma)

Keeping Pace With Adaptive Design (Life Science Leader) (Outsourcing Pharma)

General Regulatory And Interesting Articles

Fear of opioid addiction keeps some cancer patients from seeking pain relief (Reuters)

Company tests a way to deliver vaccines by a skin 'patch' (BioFlash)

Clockwork heart pacemaker does away with batteries (Reuters)

Electronic nose ‘smells’ C-diff (OnMedica)

Bioelectronic medicine: Milestones on the way to medical revolution (Eye for Pharma)

UK cancer death rate for children drops 22% in a decade (Pharma Times)

More Evidence That ADHD Drugs Don't Curb Ultimate Height (NPR)

Regulatory Reconnaissance #390 – 2 September 2014

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.