Regulatory Focus™ > News Articles > Regulatory Reconnaissance (24 April 2013)

Regulatory Reconnaissance (24 April 2013)

Posted 24 April 2013 | By Alexander Gaffney, RAC 

Good morning and welcome to another edition of Regulatory Reconnaissance.

In Focus: US

  • CDER Revamping Quality Regulation, Plans Metrics-Based Surveillance (FDA News) ($)
  • Novartis Is Sued By The Feds For A Huge Kickback Scheme (Pharmalot) (DOJ) (Reuters) (NYTimes) (AP)
  • New FDA Staff Manual for Coordination of Drug, Biologic and IVD Labeling Activities (FDA)
  • Hamburg's Speech Cites Resource Challenges Facing Agency (FDA)
  • Report from Influential Think Tank Recommends Changes to REMS, 'Pay for Delay' (BPC)

In Focus: International

  • Compounding Issues Reach Canada as Regulators Propose New Framework (Health Canada)
  • WHO Issues New Pharmaceuticals Newsletter (WHO)
  • Taiwan FDA Unveils Pharmaceutical Regulatory Easing (Taiwan Today)
  • Nice Approves Xarelto, Xolair, Esbriet, Orencia for NHS Use
  • To Crack Down On Prescription Drug Abuse, We May Need To Build A Better Pill Bottle (Think Progress)

Comments? Suggestions? Shoot me an email at news@raps.org.

US

Pharmaceuticals/Biotechnology
  • Compounding Recall Cites Sterility Problems-Sound Familiar? (FDA)
  • CDER Revamping Quality Regulation, Plans Metrics-Based Surveillance (FDA News) ($)
  • Novartis Is Sued By The Feds For A Huge Kickback Scheme (Pharmalot) (DOJ) (Reuters) (NYTimes) (AP)
  • New FDA Staff Manual for Coordination of Drug, Biologic and IVD Labeling Activities (FDA)
  • FDA Approved Another Drug Despite Ongoing Investigation of Lab Misconduct (ProPublica)
  • New FDA MAPPP for the Cover Forms for Drug Master Files (FDA)
  • North Carolina to get $359,571 as part of kickback settlement against Amgen (Med City News)
  • Panel of R&D execs say tweaks needed to boost drug-development process (Fierce Biotech)
  • J&J getting OTC plant problems whipped (Fierce Pharma Manufacturing)
  • Pfizer Escapes Shareholder Suit Over Wyeth Alzheimer's Drug (Law 360) ($)
  • Orphan Drugs To Make Up 16% Of Rx Market By 2018, Says Evaluate Pharma (The Pink Sheet) ($)
  • Janssen Releases Phase 3 HCV Data (J&J) (Drug Discovery and Development)
  • Guilty Plea Expected In Fake-Drugs Case (WSJ)
  • FDA approves second BD Rx generic injectable drug (DSN) (BioSpace)
  • California's Draft Inference Regulation (RxTrace)
  • FDA Using MiniSentinel to Assess Risks of Acute Myocardial Infarction and Use of Anti-Diabetes Drugs (Mini Sentinel)
  • Teva and Xenon Announce FDA Orphan Drug Designation for Pain Drug XEN402 (Business Wire)
  • Sucampo/Takeda drug Amitiza wins 1st FDA nod in OIC non-cancer pain (SCRIP Intelligence) ($) (Takeda) (Business Wire) (Bloomberg)
  • CytRx Announces Agreement with FDA on Special Protocol Assessment for Global Pivotal Phase 3 Clinical Trial with Aldoxorubicin for Soft Tissue Sarcoma (CytRx) (FDA News) ($)
  • FDA Making Good on GAIN Act's Antibiotic Goals (FDA News) ($)
  • Sources Sought for a Study to Investigate the Sensitivity of Pharmacokinetics in Detecting Differences Physicochemical Properties (FDA)
  • Solicitation: Therapeutic Equivalence of Generic Iron Complex Product (FDA)
  • TiGenix 'remarkable' early stem cell success in rheumatoid arthritis (SCRIP Intelligence) ($)
  • FDA's OxyContin Ruling May Spur New Battles Over Generics (Law 360) ($)
  • FDA Approves Labeling Revisions for Oak Pharms Akorn's Cogentin (NDA #012015) (FDA)
  • FDA Approves Manufacturing Changes for Cephalon's Actiq, Daiichi Sankyo's Welchol and Fresenius Kabi's Naropin (FDA)
  • Novartis Profit Rises 7% on Lack of Generic Diovan (Bloomberg)
  • Suspended North Side Pharmacist Indicted for Allegedly Smuggling and Trafficking Counterfeit Viagra (FDA)
  • Florida Woman Sentenced to Serve 72 Months in Prison for Conspiring to Distribute Prescription Drugs Over the Internet (FDA)
Medical Devices
  • CareFusion Alaris PC Unit with Software V9.12: Class 1 Recall - Communication Error When Attached to EtCO2 or SpO2 Modules (FDA) (FDA) (Fierce Medical Devices)
  • Stryker's New Claims Against XL In Knee Suit Meet Resistance (Law 360) ($)
  • Questions over Gene Patents Shake Diagnostics Industry (MIT Technology Review)
  • Aspect Imaging lands FDA clearance for wrist MRI (Mass Device)
  • InspireMD soars on FDA green light to begin clinical trial (Mass Device)
  • Questions arise about robotic surgery's cost, effectiveness (Med City News)
  • New Comments on FDA's Docket Classifying Four Class III Premandment Devices (FDA)
Assorted
  • Hamburg's Speech Cites Resource Challenges Facing Agency (FDA)
  • Report from Influential Think Tank Recommends Changes to REMS, 'Pay for Delay' (BPC)
  • Recalls Of Dietary Supplements Highlight Mystery Ingredients (NPR)
  • Chronic Fatigue Syndrome Presents Challenging Test Case For PDUFA V Program (The Pink Sheet Daily) ($)
  • Comment Request; Protection of Human Subjects: Informed Consent; Institutional Review Boards (FDA)
  • Best Practices Innovation Collaborative (IOM)
  • NAD Recommends InterHealth Modify Advertising for Zychrome (Nutraceuticals World)
Government and Budget
  • Reports: Obamacare architect Baucus to step down at year's end (Mass Device)
  • CBO Says Regulatory Reforms for Pharmaceuticals Might Promote Innovation (CBO)
  • Senate committee backs nominee for CMS post, Marilyn Tavenner (BioCentury) (Med Page Today)
  • OMB identifies up to $800 billion in benefits from regulations since 2002 (The Hill)
Warning Letters
  • (Medical Device) Alveologic for Misbranding on its Website (FDA)
  • (Medical Device) Oy Ajat for QSR, MDR Violations (FDA)
  • (Medical Device) KayPENTAX for CGMP (FDA)
  • (Medical Device) Excel Medical Products for QSR, MDR, Adulteration (FDA)
  • (Pharmaceutical) Macular Vitamin for Misbranding, New Drug Violations (FDA)
  • (Pharmaceutical) Women's Health Institute for Misbranding, New Drug Violations (FDA)
Upcoming Meetings and Events
  • 22 April 2013: Public Meeting - International Consortium of Cardiovascular Registries (FDA)
  • 23 April 2013: FDA Webinar: Home Use of Diabetes and Cardiovascular Medical Devices (FDA)
  • 23 April 2013: Margaret Hamburg to Keynote FDLI's Conference (FDLI) (Speech)
  • 23 April 2013: FDA Listening Meeting on Use of Antibiotics in Animals in Olympia, WA (FDA)
  • 25 April 2013: Securing Our Nation's Prescription Drug Supply Chain (Energy and Commerce Committee)
  • 25-26 April 2013: Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee Meeting (FDA) (Meeting Materials Posted)
  • 25-26 April 2013: Drug Development for Myalgic Encephalomyelitis and Chronic Fatigue Syndrome (ME and CFS) (FDA)
  • 26 April 2013: Senate Appropriations Committee to Markup FDA Bill (Appropriations)
  • 26 April 2013: Does HIPAA Help or Hinder Patient Care and Public Safety? (Energy and Commerce Committee)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (Eye on FDA) (FDA)

International

  • Compounding Issues Reach Canada as Regulators Propose New Framework (Health Canada)
  • WHO Pharmaceuticals Newsletter (WHO)
  • Taiwan FDA unveils pharmaceutical regulatory easing (Taiwan Today)
  • European Commission reports on MoU on the sale of counterfeit goods (The Pharma Letter) ($)
  • Patent climate improves for UK and European medtech filers (SCRIP Regulatory Affairs) ($)
  • BMS wins wider NICE Orencia arthritis approval (PMLive)
  • NICE final yes for pulmonary fibrosis drug Esbriet (Pharma Times) (The Pink Sheet) ($)
  • Xolair gains final NICE approval (Pharma Times)
  • NICE recommends Xarelto for PE (Cardiovascular Business)
  • 400 India Drug Makers Said To Have Complied With Essential Drug Pricing (PharmAsia News) ($)
  • Medivir: Marketing Authorization Application for Simeprevir to the EMA for the treatment of patients with genotype 1 and genotype 4 hepatitis C is now filed (Business Wire)
  • UK review warns on cosmetic injections, urges tougher rules (Reuters)
  • Ghananians cautioned against fake drugs (Ghana Web)

General Regulatory and Interesting Articles

  • Is There a Link Between Antidepressants and Autism? (Pharmalot)
  • Catch-22, Clinical Trial Edition: The Double Bind for Women and Children (Scientific American)
  • New Technology Shows Promise for Reinventing Drug Discovery (MedIndia)
  • Four Lessons From IBM And Roche's Failed DNA Collaboration (Forbes)
  • Social Media: More Likely To Identify Bad Medicines -- Or Tarnish Good Ones? (Forbes)
  • Animal-rights activists wreak havoc in Milan laboratory (Nature)
  • To Crack Down On Prescription Drug Abuse, We May Need To Build A Better Pill Bottle (Think Progress)
  • Sofosbuvir Offers High Cure Rate For Two Hepatitis C Subtypes (Medical News Today)

Regulatory Reconnaissance #52 - 24 April 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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