Regulatory Focus™ > News Articles > Regulatory Reconnaissance (28 May 2013)

Regulatory Reconnaissance (28 May 2013)

Posted 28 May 2013 | By Alexander Gaffney, RAC

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

In Focus: US

  • B&L Unit To Pay $34M For Drug Marketing Guilty Plea: DOJ (DOJ) (Law 360) (The Pharma Letter) (The Hill)
  • Heart Device Approval Delays Leave US Doctors Frustrated (Reuters)
  • Spinning RECORD: Battle Over Rosiglitazone Heats Up Two Weeks Before Crucial FDA Meeting (Forbes) (Steven Nissen) (GSK) (FDA)
  • If Sponsors Don't Ask, FDA Can't Always Deliver: Merck's Suvorexant Dosing Debacle (The Pink Sheet)
  • Valeant Receives CRL from FDA for Efinaconazole (PR Newswire) (Reuters)
  • Would A US Federal Pedigree Law Require A New User Fee Act? (RxTrace)

In Focus: International

  • EMA Updates Inspector Expectations for API Audits (In-Pharma Technologist)
  • India's CDSCO Streamlines its Licensing Authority (PharmaBiz)
  • WHO Expert Committee Releases Specifications for Pharmaceutical Preparations (WHO)
  • Analysis: ENVI's IVD Regulation Amendments (Med Devices Legal)
  • Australia's TGA Finds Bayer Broke Advertising Regulations (TGA)
  • Novartis study scandal sending shockwaves through Japanese medical research community (Mainichi) (Fierce)
  • Pharma Industry Accused of Testing Drugs in Countries With Lax Regulation (DW.DE)
  • Five Years, Two Products: Is the EU's Advanced Therapies Legislation Working? (Scrip Intelligence)

Comments? Suggestions? Email me at news@raps.org.

US

Pharmaceuticals/Biotechnology
  • B&L Unit To Pay $34M For Drug Marketing Guilty Plea: DOJ (DOJ) (Law 360) (The Pharma Letter) (The Hill)
  • Spinning RECORD: Battle Over Rosiglitazone Heats Up Two Weeks Before Crucial FDA Meeting (Forbes) (Steven Nissen) (GSK) (FDA)
  • If Sponsors Don't Ask, FDA Can't Always Deliver: Merck's Suvorexant Dosing Debacle (The Pink Sheet)
  • Valeant Receives CRL from FDA for Efinaconazole (PR Newswire) (Reuters)
  • OPDP Discusses Latest Batch of Enforcement Letters, Addresses Hot Topics (CHC)
  • Forest Labs Subpoenaed Over New COPD Inhaler (Law 360)
  • Would A U.S. Federal Pedigree Law Require A New User Fee Act? (RxTrace)
  • Biomarkers In Orphan Studies Still Need Past Experience, FDA Says (The Pink Sheet)
  • Basilea antifungal wins coveted U.S. drug status (Reuters)
  • FDA Grants Breakthrough Therapy Designation to Alexion's Asfotase Alfa (Boardvote)
  • Astellas announces isavuconazole orphan drug designation by U.S. FDA (Astellas)
  • AstraZeneca to acquire Omthera Pharmaceuticals including NDA-ready novel dyslipidemia treatment to complement cardiovascular portfolio (AstraZeneca)
  • Pharmaxis slashes staff after FDA red-flags cystic fibrosis treatment (Fierce)
  • Novo Nordisk on track to file liraglutide in obesity (PMLive)
  • Compounders Plan to Storm Capitol Hill to Save an Industry 'Under Siege' (FDA News)
  • Compounders Complain FDA Turning too Strict (French Tribune) (Augusta Chronicle)
  • Compounding A Crisis At FDA (Forbes)
  • New Report Documents a Decade of Safety Violations by Compounding Pharmacies (US PIRG)
  • Lupin Must Produce Generic Info In Warner Chilcott Suit (Law 360)
  • US Appeals Court puts temporary stop on sales of generics of AstraZeneca's Pulmicort Respules (The Pharma Letter) (AstraZeneca)
  • Repros Needs Another Mid-Stage Trial ForProellex In Uterine Fibroids (The Pink Sheet)
  • Capsule Seller Can't Duck Suit Over Testosterone Claims (Law 360)
  • Fresenius Kabi USA Initiates Voluntary Recall of Single Lot of Magnesium Sulfate (Business Wire)
  • Potential "universal" influenza vaccine developed and tested at FDA (FDA)
  • Cempra wins $17.7M BARDA contract for solithromycin in pneumonia, biothreats (SCRIP Intelligence)
  • Scientists Look to Obtain FDA Approval for Traditional Chinese Herbal Remedies (CNN)
Medical Devices
  • Heart device approval delays leave U.S. doctors frustrated (Reuters)
  • DePuy Loses Bid To Toss $8.3M Hip Implant Verdict (Law 360) (Mass Device)
  • FDA makes Zilver stent Class I recall (Cardiovascular Business) (Med Page Today) (FDA)
  • March 2013 PMA Approvals (FDA)
  • Clinical Studies Needed For Nonthermal Shortwave Diathermy Devices, FDA Panel Says (The Gray Sheet)
  • Genome Patents Create Landmines for Medical Device Industry (MDDI)
  • Hill-Rom wins 510(k) clearance for its MetaNeb airway clearing system (Mass Device)
  • FDA clears new smartphone health monitoring technologies (Mass Device)
  • FDA Audit Slows Down Medtronic Launch Plans For Low-Glucose-Suspend Diabetes System (The Gray Sheet)
  • FDA gives Arcos a nod for its burn therapy device (Mass Device)
  • Signostics wins FDA go-ahead for handheld ultrasound device (Mass Device)
  • Sensus Healthcare Receives FDA Clearance to Treat Keloids with the SRT-100 (PR Newswire)
  • Three reasons FDA's enforcement helps mobile health (Mobi Health News)
  • Intuitive wins first da Vinci trial; stock jumps (Fierce) (Mass Device)
  • FDA clears 21-inch medical monitors from NEC Display Solutions (Mass Device)
  • H.R.2085 -- Diagnostic Innovation Testing and Knowledge Advancement Act of 2013 (Introduced in House - IH) (Congress)
Assorted and Government
  • Is the US Safer Thanks to Biodefense Efforts? (BioCenturyTV) (FDA-Focused Segment)
  • FDA Still not Permitted to Spend Some of its User Fees (Strengthen FDA)
  • Patient educational material too complex for average consumers (World of DTC Marketing)
  • C-Path, IMI consortia in biomarkers deal (BioCentury) (CPath)
  • OMB Rejects FDA Submission on Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act (OMB)
  • US PTO Releases Updated Burden Estimate for Hatch-Waxman Act (US PTO)
  • OMB Approves FDA Collection on Dietary Supplement Labeling, Environmental Impact Considerations (OMB) (OMB)
  • After 37 years, U.S. chemical-safety laws may finally get an overhaul (Washington Post) (Congress) (KH Law) (PETA)
  • Coalition seeks tax reforms to spark innovation investment (SCRIP Intelligence)
  • CBO Scores the Animal Drug User Fee Amendments of 2013 (CBO)
  • Obamacare Will Bring Drug Industry $35 Billion In Profits (Forbes)
  • FTC Announces Agenda, Panelists for Upcoming Mobile Security Forum (FTC)
Upcoming Meetings and Events
  • 29-30 May 2013: Medical Countermeasure Regulatory Science Symposium (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)

International

  • EMA Updates Inspector Expectations for API Audits (In-Pharma Technologist)
  • India's CDSCO Streamlines its Licensing Authority (PharmaBiz)
  • WHO Expert Committee on Specifications for Pharmaceutical Preparations (WHO)
  • ENVI's IVD regulation amendments (Med Devices Legal)
  • Australia's TGA Finds Bayer Broke Advertising Regulations (TGA)
  • Novartis study scandal sending shockwaves through Japanese medical research community (Mainichi) (Fierce)
  • Pharma industry accused of drug testing in poorer countries with lax regulation (DW.DE)
  • Five years, two products: is the EU's advanced therapies legislation working? (Scrip Intelligence)
  • European Commission Publishes Revised Module on Administrative Information Application Form (EC)
  • Recent Violence Targeted At Doctors In China Could Spell Trouble For Clinical Trials (The Pink Sheet)
  • J&J Recalls Programmable Valves in Australia Due to Malfunctions (TGA)
  • France Provides Update on Recall of Ceraver's Joint Prostheses (ANSM)
  • Pfizer denies knowledge of acquired companies' failures in East German drug trials (Fierce)
  • Australia And New Zealand Make Progress Toward ANZTPA Integration - AusMedtech Conference (PharmAsia News)
  • EMA Publishes New Policy on its Support for Staff Subject to External Criticism (EMA)
  • EU HTA Net's WP5 Strand B's Procedure Manual V3 is now available (EUnetHTA)
  • Indian plans for informed consent could pose challenges (SCRIP Intelligence)
  • INTERVIEW: New Philippines FDA chief brings maturity for deregulation (SCRIP Intelligence)
  • Dual filings for TaiGen's nemonoxacin blaze cross-strait trail (SCRIP Intelligence)
  • At what cost? Life-saving drug withheld in UK by NICE (The Independent)
  • Big rise in volunteers for UK medical trials (BBC)
  • EU approves Xarelto label expansion (BioCentury) (PMLive) (The Pharma Letter)
  • FzioMed's post-surgical gel lands a regulatory win in Australia (Mass Device)
  • Surprise! Notified bodies will drop by unexpected every 5 years (Clinica)
  • DCGI Mulls Response Plan For India-Made Drugs Subject Of Foreign Alerts (PharmAsia News) (India Times)
  • Ranbaxy under scanner of DCGI, but approvals to its drugs in India as per norms (PharmaBiz)
  • Indian pharma companies filed 417 DMFs in US during 2012 and 79 in Q1 of 2013 (PharmaBiz)
  • Boston Scientific Receives CE Mark Approval For GUIDE DBS System (Boston Scientific)
  • Sinovac Receives Updated cGMP Accreditation from CFDA (In-Pharma Technologist)
  • Australians "denied new drugs because of too-difficult PBS listing" (Pharma Times)

General Regulatory and Interesting Articles

  • Regulatory Compliance Challenges Remain a Concern for Life Sciences Manufacturers (Manufacturing Geek)
  • Cholesterol drugs may not lower heart attack risk, study says (CBS)
  • 2-Year-Old Drug Takes Top Rx Slot from Warfarin (Med Page Today)
  • Video game aims to help young cancer patients (CNN)

Regulatory Reconnaissance #75 - 28 May 2013

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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

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


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