Recon

October 1, 2014

by Alexander Gaffney, RAC

Regulatory Recon: FDA’s Cybersecurity Guidance Launches New Zohydro Filed With FDA (1 October 2014)

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

In Focus: US

FDA Releases Final Cybersecurity Guidance (FDA) (FDA)
FDA Unveils new Strategic Priorities Roadmap (FDA) (FDA)
US Sunshine Act Database Launches (ProPublica) (NYTimes) (Pharmalot) (Reuters) (Vox) (BIO) (Pink Sheet-$) (Gray Sheet-$) (WSJ-$) (Bloomberg) (AdvaMed)
New FDA User Fees go Into Effect Today (FDA)
Med tech attorneys say FDA ramping up monitoring of device promotion (Fierce)
Indian firm, 26 others cited for failing to pay GDUFA fees (In-Pharma)
Hospira Hit With Warning Letter for Australia cGMP Deficiencies (Hospira)
Valeant has a Wrinkle: FDA Warning Letter Cites Problems With a Facial Filler (Pharmalot) (RTT) (Press) (Law 360-$)
FDA Sets User Fee for Rare pediatric Disease priority Review Voucher (FDA)
FDA Twitter Policy Offers Loophole For Promoting Black-Box Drugs (Pink Sheet-$)
Zogenix Submits Modified Formulation of Zohydro(R) ER With Potential Abuse Deterrent Properties for FDA Review (Press)
Alameda Country, CA Drug Disposal Ordinance Upheld in Court (Press) (Pharmalot)
FDA Issues Draft Guidance on LDTs (GEN) (FDA) (FDA) (BioCentury)
First Ebola case diagnosed in the United States: CDC (Reuters) (WaPo) (White House) (NPR) (CDC)

In Focus: International

Health Canada bans some drug imports from India (Canada Journal) (Press) (India Times) (Toronto Star)
International device regulators’ single-audit program kicks off (Clinica-$)
UK regulator removes need to report all adverse drug reactions in children (PharmJournal) (Nursing Times)
Adaptive Licensing: Industry On Board, With Caveats (In Vivo-$)
Facilitating applications for paediatric investigation plans (EMA)
France Will use Taxes to Pressure Drug Makers on Hep C Prices (Pharmalot) (Reuters)
CDSCO upgrades manpower to implement GMP across manufacturing facilities in the country (PharmaBiz)
India’s draft rules on patenting drugs draw mixed response (Live Mint)
India set to run out of critical free drug for HIV/AIDS program (Reuters)

US: Pharmaceuticals and Biotechnology

Indian firm, 26 others cited for failing to pay GDUFA fees (In-Pharma)
Hospira Hit With Warning Letter for Australia cGMP Deficiencies (Hospira)
Valeant has a Wrinkle: FDA Warning Letter Cites Problems With a Facial Filler (Pharmalot) (RTT) (Press) (Law 360-$)
FDA Sets User Fee for Rare pediatric Disease priority Review Voucher (FDA)
FDA Twitter Policy Offers Loophole For Promoting Black-Box Drugs (Pink Sheet-$)
Strides Arcolab Hit With FDA Import Alert; Company Says Products Not Meant for US (India Times) (Fierce) (FDA)
How the rise of generic drugs affects pharmaceutical innovation (TIE) (NBER)
FDA’s Bob Rappaport on Anesthesia and How FDA Tests it on Children (FDA)
Engaging with the FDA During New Drug Development (FDA)
Harvard Pilgrim awarded FDA contract for drug monitoring (Boston Globe)
Push for Mutual Reliance on EU-FDA Inspections Gets Underway (FDA News-$)
US Definitions, Current Use, and FDA Stance on Use of Platelet-Rich Plasma in Sports Medicine. (PubMed)
Have Hefty DOJ Fines Made Pharma Marketers More Compliant with FDA Regulations? (Pharma Marketing Blog)
Advancing the Use of Biomarkers and Pharmacogenomics in Drug Development (Brookings)
Does Adversity In BioPharma Manufacturing Build Character Or Reveal It? (LifeSciLeader)
FDA Publishes Target Animal Safety Data to Support Drug Applications for Potassium Bromide to Control Seizures in Dogs (FDA)
Of Federal Authority and the Ability to Sue Compounding Pharmacies (D&D Law)
Eli Lilly Sued Over Marketing of Testosterone Drug (NJ Law Journal-$)
Hikma Pharmaceuticals Gets FDA Approval For Colchicine Capsules (Press)

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

Zogenix Submits Modified Formulation of Zohydro(R) ER With Potential Abuse Deterrent Properties for FDA Review (Press)
Insys Therapeutics' Cannabidiol Receives FDA Orphan Drug Designation (Press)
Ardelyx irritable bowel syndrome drug succeeds in mid-stage trial (Reuters)
Portola Pharma drug reverses effect of anti-clotting drugs in study (Reuters) (Press)

US: Pharmaceuticals and Biotechnology: General

Alameda Country, CA Drug Disposal Ordinance Upheld in Court (Press) (Pharmalot)
NIH Seeks to Improve Vaccine Response with New Adjuvants (PharmTech) (BioCentury)
New cancer therapy comes of age, cost a 'toxic' side effect (Reuters)
New Viagra ads target women for 1st time by encouraging them to push men to get treatment (Star Tribune)
Genentech's distribution change for cancer drugs upsets hospitals (Modern Healthcare)

US: Medical Devices

FDA Releases Final Cybersecurity Guidance (FDA) (FDA)
Med tech attorneys say FDA ramping up monitoring of device promotion (Fierce)
FDA Issues Draft Guidance on LDTs (GEN) (FDA) (FDA) (BioCentury)
FDA Unveils Medical Device Regulatory Case Studies (FDA)
FDA Releases Paper on brain-computer Interface Devices (FDA)
Trinity Biotech expects FDA submission in early 2015 for heart failure Dx (Fierce)
Class 1 Recall for Teleflex’s Hudson RCI pediatric Anesthesia Breathing Circuits (FDA)
Endo to Settle Legal Claims Concerning Vaginal Mesh Products (WSJ-$) (Law 360-$)
3D Technologies Poised to Change How Doctors Diagnose Cancers (FDA)
Philips Secures 510(k) Clearance to Market the First Clinical Applications for its new Digital Health Platform (Press)
Nova StatStrip, a Hematocrit and Electrochemical Interference Correcting Clinical Glucometer, FDA Cleared (MedGadget)
FDA Clearance Makes MAGEC System Available to More Patients (Press)

US: Assorted And Government

FDA Unveils new Strategic Priorities Roadmap (FDA) (FDA)
US Sunshine Act Database Launches (ProPublica) (NYTimes) (Pharmalot) (Reuters) (Vox) (BIO) (Pink Sheet-$) (Gray Sheet-$) (WSJ-$) (Bloomberg) (AdvaMed)
New FDA User Fees go Into Effect Today (FDA)
FDA awards grants to stimulate drug, device development for rare diseases (FDA) (Gray Sheet-$)

Upcoming Meetings

RAPS' FDA Scientific Advisory Committee Meeting Tracker

Ebola Outbreak

First Ebola case diagnosed in the United States: CDC (Reuters) (WaPo) (White House) (NPR) (CDC)
100 doses of Ebola drug available: Sarepta CEO (CNBC)
Ebola Case Causes Surge of Interest in Drug Company Stocks (CNBC) (BioCentury) (SCRIP-$)
NanoViricides Synthesizing Ebola Drug Candidates (Press)

Europe

UK regulator removes need to report all adverse drug reactions in children (PharmJournal) (Nursing Times)
Draft guideline on core SmPC for human plasma derived and recombinant coagulation factor IX products (EMA)
Draft concept paper on the revision of the guideline on the development of new medicinal products for the treatment of ulcerative colitis (EMA)
Draft concept paper on the revision of the guideline on the development of new medicinal products for the treatment of Crohn’s disease (EMA)
EMA Pilot Eventually Could See Permanent Patient Presence At The CHMP (Pink Sheet-$)
Adaptive Licensing: Industry On Board, With Caveats (In Vivo-$)
Facilitating applications for paediatric investigation plans (EMA)
Taking Part In The Adaptive Licensing Experiment (In Vivo-$)
Why earlier access requires earlier dialogue (TOPRA)
France Will use Taxes to Pressure Drug Makers on Hep C Prices (Pharmalot) (Reuters)
UK alliance to accelerate development of advanced therapies (Pharma Times)
IntelGenx and RedHill Biopharma Submit European Marketing Authorization Application for Migraine Drug RIZAPORT (Press)
EDP Biotech Announces CE Mark Approval for ColoMarker an in Vitro Diagnostic Aid in Early Detection of Colon Cancer and Plans for Commercialization in Europe (Press)

India

CDSCO upgrades manpower to implement GMP across manufacturing facilities in the country (PharmaBiz)
India’s draft rules on patenting drugs draw mixed response (Live Mint)
India set to run out of critical free drug for HIV/AIDS program (Reuters)
Indian Govt urged to launch online registration forum for manufacturing and marketing cos to regulate drug distribution system (PharmaBiz)
Medical devices industry demands de-listing of Schedule M-III from Schedule M (PharmaBiz)
Indian government takes action over dubious fixed-dose combinations (Pharma Letter-$)
Indian Court seeks clarity on price regulator's action (SCRIP-$) (India Times)

Canada

Health Canada bans some drug imports from India (Canada Journal) (Press) (India Times) (Toronto Star)
23andMe Launches DTC Genetic Testing Service in Canada (Daily Courier)

Other International

International device regulators’ single-audit program kicks off (Clinica-$)
IMDRF Posts Meeting Minutes from DC meeting (IMDRF)

Clinical Trials

Reproducible science and randomized clinical trials (TIE)
Response to TransCelerate’s Risk-Based Monitoring Paper: Technology Considerations to Enable Risk-Based Monitoring Methodology (BioClinica)

General Regulatory and Interesting Articles

GlaxoSmithKline deepens its commitment to 'electroceuticals' (Fierce) (MedCityNews)
Plant-based vaccines challenge big pharma for $3 billion flu market (Reuters)
Drug Patents Held Overseas Can Pare Makers’ Tax Bills (NYTimes)
Charities must be clear about pharma funding (Pharmafile)

Regulatory Reconnaissance #411 – 1 October 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 [email protected].

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

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