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Journal Cover Consumer Drugs
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   Full-text available via subscription Subscription journal
   ISSN (Print) 1530-1206
   Published by Informa plc Homepage  [9 journals]
  • Perrigo Consumer Results' Significance Grows With Tysabri In Past
    • Abstract: Firm reclassifies previous revenues from its now-divested license for Tysabri royalties, garnering tax benefits in earlier periods. Perrigo?s review of...      Related Stories
      Could The EMA Be A Regulatory Model For East Africa?
      Recent And Upcoming FDA Advisory Committee Meetings
      FDA?s NDA And BLA Approvals: Kevzara 
      PubDate: Fri, 26 May 2017 15:00:01 GMT
       
  • J&J Settlement With States Not Likely To Be Precedent In OTC Space
    • Abstract: J&J?s agreement with 42 states and Washington, D.C. is its latest cost from widespread GMP problems that prompted recalls and...      Related Stories
      Could The EMA Be A Regulatory Model For East Africa?
      Recent And Upcoming FDA Advisory Committee Meetings
      FDA?s NDA And BLA Approvals: Kevzara 
      PubDate: Thu, 25 May 2017 19:35:55 GMT
       
  • Consumer Health Weekly Trademark Review May 16, 2017
    • Abstract: Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) compiled from the Official Gazette of the U.S. Patent and...      Related Stories
      Biomarker-Led Claim Is Small Step For Merck?s Keytruda, Giant Leap For Cancer Indications
      European CHMP Recommendations & MAA Updates
      New EudraVigilance System To Usher In Simplified Reporting of ADRs From Nov. 22 
      PubDate: Tue, 23 May 2017 20:05:55 GMT
       
  • Coppertone ‘Assurance Assessment’ Anticipates Criticism From
           Sunscreen Reviews
    • Abstract: Bayer shares results from a consulting firm?s assessment of its operations, procedures and testing at the root of Coppertone SPF...      Related Stories
      EMA Consults On Managing Serious Breaches Under EU Clinical Trials Regulation
      Ethiopia?s Dr Tedros New WHO Head
      New Standard Of Care Secures EU OK For Neuroblastoma Drug 
      PubDate: Mon, 22 May 2017 15:00:02 GMT
       
  • OTC Monograph User Fees Totaling $22m To $34m Floated In Senate Discussion
           Draft
    • Abstract: Bulk of user fees would be raised through facility fees, under Sens. Isakson and Casey’s discussion draft, but there?s little...      Related Stories
      Two-Tier OTC Monograph Approach Could Come With User Fee Revamp
      Manufacturing Regulatory Updates In Brief
      Data Integrity Problems Remain FDA Investigators? Focus 
      PubDate: Fri, 19 May 2017 19:30:46 GMT
       
  • Two-Tier OTC Monograph Approach Could Come With User Fee Revamp
    • Abstract: One tier could provide two-year exclusivity, should FDA request clinical trials for new conditions or ingredients, under a US Senate...      Related Stories
      OTC Monograph User Fees Totaling $22m To $34m Floated In Senate Discussion Draft
      Manufacturing Regulatory Updates In Brief
      Data Integrity Problems Remain FDA Investigators? Focus 
      PubDate: Fri, 19 May 2017 19:30:42 GMT
       
  • OTC Topicals Firm's Regulatory Problems More Than Skin Deep
    • Abstract: FDA?s warning letter submitted following an October 2016 at Phillips Co.?s Millerton, Okla., facility states that the company does not...      Related Stories
      EMA Guide On Trial Master Files To Help Compliance With Upcoming CT Regulation
      Outpatient Rx Safety Meeting To Spotlight Health Literacy, Provider Communication
      Invokana Adds Warnings On Amputation Risk, But Will It Give Jardiance An Edge? 
      PubDate: Tue, 16 May 2017 17:15:54 GMT
       
  • Consumer Health Weekly Trademark Review May 9, 2017
    • Abstract: Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) compiled from the Official Gazette of the U.S. Patent and...      Related Stories
      EMA Guide On Trial Master Files To Help Compliance With Upcoming CT Regulation
      Outpatient Rx Safety Meeting To Spotlight Health Literacy, Provider Communication
      Invokana Adds Warnings On Amputation Risk, But Will It Give Jardiance An Edge? 
      PubDate: Tue, 16 May 2017 01:22:58 GMT
       
  • FDA's OTC Naloxone Study Is A Starting Point For Other Switches,
           Not A Roadmap
    • Abstract: CDER has been studying ideas such as pictograms to communicate instructions on administering opioid-reversal medication, but officials can’t predict when...      Related Stories
      EMA Guide On Trial Master Files To Help Compliance With Upcoming CT Regulation
      Outpatient Rx Safety Meeting To Spotlight Health Literacy, Provider Communication
      Invokana Adds Warnings On Amputation Risk, But Will It Give Jardiance An Edge? 
      PubDate: Tue, 16 May 2017 01:18:08 GMT
       
  • Smartphone Apps Appropriate For OTC Product Instructions –
           Consultant
    • Abstract: “The present has passed us by” in using appropriate technology to provide consumers more information than on US Drug Facts...      Related Stories
      EMA Guide On Trial Master Files To Help Compliance With Upcoming CT Regulation
      Outpatient Rx Safety Meeting To Spotlight Health Literacy, Provider Communication
      Invokana Adds Warnings On Amputation Risk, But Will It Give Jardiance An Edge? 
      PubDate: Mon, 15 May 2017 18:35:44 GMT
       
  • Codeine Concerns Cough Up FDA's OTC Monograph Problems
    • Abstract: Pew Charitable Trusts joins CHPA, medical groups in urging Congress to authorize moving the US monograph system to an administrative...      Related Stories
      FDA Advisory Committee Votes Against Compounding Of Coated Modified Release Drugs
      FDA?s NDA And BLA Approvals: Radicava, Minolira, Bavencio
      Recent And Upcoming FDA Advisory Committee Meetings 
      PubDate: Thu, 11 May 2017 17:05:15 GMT
       
  • Consumer Health Weekly Trademark Review May 2, 2017
    • Abstract: Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) compiled by from the Official Gazette of the U.S. Patent...      Related Stories
      Stability At Last For Drug Innovators And Pricing In Australia
      Black Box ?Best Case? Hopes On Vaginal Estradiol Dashed For TherapeuticsMD
      Sanofi?s Drug Pricing Pledge Ties Increases To National Health Expenditure 
      PubDate: Tue, 09 May 2017 18:05:38 GMT
       
  • 'Do Not Flush' Labels For Acne, Hemorrhoid Wipes Won't Stop
           Consumers – CHPA
    • Abstract: Consumer products group hopes a Washington, D.C., mandate for "do not flush labeling on nonwoven disposable wipes" beginning in...      Related Stories
      Ireland Promotes Dublin As ‘Natural Destination For EMA’ After Brexit
      User Fee Add-Ons: Senate Bill Tweaks Orphans, Opioids, Importation
      Pediatric Study Timelines Could Change Under Senate PDUFA Bill 
      PubDate: Mon, 08 May 2017 14:01:30 GMT
       
  • Navigating Amazon: E-Commerce Giant Critical For OTC Drug Sales
    • Abstract: As Amazon emerges as the leading search engine for information about consumer packaged goods products, OTC drug and other consumer...      Related Stories
      Recent And Upcoming FDA Advisory Committee Meetings
      EMA Considering Guideline On Evaluating Novel Antivirals for Influenza
      Current FDA Policy Uncertainties Could Yield ?Reverse Impact? Of Support 
      PubDate: Thu, 04 May 2017 17:09:27 GMT
       
  • Petition Seeks OTC PPI Warning On Cancer Risk From Persistent Heartburn
    • Abstract: OTC proton pump inhibitors should carry a warning that the products do not eliminate risks of esophageal cancer from persistent...      Related Stories
      Returns From Sanofi Consumer Expansion Could Point To More
      European Commission To ‘Explain And Discuss’ Contentious GMP Guide For ATMPs
      Suspense Continues Over Formal EMA Hosting Criteria, October Decision On New Home Likely 
      PubDate: Tue, 02 May 2017 19:00:07 GMT
       
  • Returns From Sanofi Consumer Expansion Could Point To More
    • Abstract: The French pharma?s strategy of driving consumer health business growth by expanding the product lineup played out during the first...      Related Stories
      European Commission To ‘Explain And Discuss’ Contentious GMP Guide For ATMPs
      Suspense Continues Over Formal EMA Hosting Criteria, October Decision On New Home Likely
      Apotex Moves To Block Coherus? Neulasta Biosimilar; Asks FDA To Require Patient Studies 
      PubDate: Tue, 02 May 2017 18:06:01 GMT
       
  • Perrigo's Return To OTC Roots Restoring Investor Confidence
    • Abstract: The OTC drug, infant and adult nutritionals, Rx generic topicals and API manufacturer?s share price has been up since it...      Related Stories
      Petition Seeks OTC PPI Warning On Cancer Risk From Persistent Heartburn
      Returns From Sanofi Consumer Expansion Could Point To More
      European Commission To ‘Explain And Discuss’ Contentious GMP Guide For ATMPs 
      PubDate: Mon, 01 May 2017 14:40:12 GMT
       
  • 'Slow-Growth' Global Trend Shakes Up P&G Product
           Strategy Start To Finish
    • Abstract: P&G’s health care segment advanced 4% in the third quarter to $1.84bn, but sales declined for its other business units...      Related Stories
      ?Slow-Growth? Global Trend Shakes Up P&G Product Strategy Start To Finish
      Canada Introduces World First 48-Hour Reporting Requirement
      EMA And Brexit: Rental Liabilities Could Add €350m To Relocation Costs 
      PubDate: Fri, 28 Apr 2017 15:14:34 GMT
       
  • Consumer Business Reliable And Right At Home At GlaxoSmithKline
    • Abstract: CEO Walmsley?s familiarity with Glaxo?s consumer health business was clear in her response to analysts? questions about the firm?s future...      Related Stories
      Blood Disorders Overtake Cancer On EMA’s PRIME Scheme
      Situation Far From Ideal But EU Network Will Survive Brexit
      US Supreme Court Appears Divided On Biosimilar Marketing Notice, Patent Dance 
      PubDate: Thu, 27 Apr 2017 17:45:04 GMT
       
  • Consumer Health Weekly Trademark Review April 18, 2017
    • Abstract: Class 3 (Cosmetics and Cleaning Preps) and Class 5 (Pharmaceuticals) compiled from the Official Gazette of the U.S. Patent and...      Related Stories
      Eteplirsen Revisited? FDA Panel To Weigh Protocol Changes For Two Sarepta Drugs
      French Study Confirms Teratogenic Risks Of Valproate; Other Drugs In The Spotlight Too
      New Combination Product Registration Rules Coming To Malaysia 
      PubDate: Mon, 24 Apr 2017 00:28:05 GMT
       
 
 
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