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The Tan Sheet
   Full-text available via subscription Subscription journal
     ISSN (Print) 1530-1206
     Published by Informa plc Homepage  [13 journals]
  • Turning Back Calendar Could Keep E-Cigarettes Available Without Approval
    • Abstract: Exercising enforcement discretion concerning the grandfather date for e-cigarettes and other products covered in FDA’s proposed deeming rule would not be the agency’s first use of the enforcement tool in implementing Tobacco Control Act regulations.
      PubDate: Fri, 06 Jun 2014 00:00:04 -040
  • With Generic Mucinex Delayed, Perrigo Will Need Alternatives To Drive
           Sales Growth
    • Abstract: Perrigo hopes to ship store-brand Mucinex expectorant products in time for the next cough and cold season, but analysts are skeptical with several targets for the launch missed already. However, the firm can drive growth through mergers and acquisitions and Rx-to-OTC growth opportunities.
      PubDate: Thu, 05 Jun 2014 00:00:00 -040
  • Ambitious Schedule For OTC Monograph Updates On FDA Unified Agenda
    • Abstract: Nearly two-thirds of FDA’s planned regulatory actions for the consumer health segment would update the OTC drug monograph, including changes to pediatric cough/cold labeling, acetaminophen dosing, oral care products with benzocaine and labeling for some laxatives.
      PubDate: Wed, 04 Jun 2014 00:00:05 -040
  • Nestle Grows Skin Care Footprint, Valeant Gains Antitrust Cover In Derma
    • Abstract: Swiss food and beverage firm Nestle grows its stake in North American skin care with its pending $1.4 billion acquisition from Valeant of five aesthetic dermatology brands, demonstrating its commitment to health and wellness, analysts say. Valeant resolves potential antitrust obstacles to its proposed Allergan acquisition.
      PubDate: Tue, 03 Jun 2014 00:00:02 -040
  • FDA Rejects Arguments On Keeping Rx PEG Products Available
    • Abstract: FDA responded to arguments in its proposed order denying drug firms’ requests to allow their RX polyethylene glycol 3350 products to remain on the market. Among the arguments, all rejected by FDA, was that a prescription PEG 3350 should be available for use by pediatric patients and that the product is not safe OTC for elderly consumers.
      PubDate: Mon, 02 Jun 2014 00:02:06 -040
  • House Appropriators Watch Clock On OTC Cough/Cold, Sunscreen Monographs
    • Abstract: House appropriators recommend FDA in June publish a proposed rule for safety and efficacy of cough/cold OTCs in pediatric populations They also direct FDA by December to complete its review of the remaining sunscreen ingredient safety and effectiveness TEA submissions.
      PubDate: Mon, 02 Jun 2014 00:02:02 -040
  • EWG Warms To Sunscreen Use, But Maintains U.S. Products Are Subpar
    • Abstract: EWG’s 2014 guide offers its perspective on available sun-protection options for U.S. consumers based on a survey of more than 700 sunscreens and SPF-labeled moisturizers. With its Sun Safety education campaign launched with the report, EWG takes a clearer advocacy stance regarding sunscreen use.
      PubDate: Mon, 02 Jun 2014 00:01:58 -040
  • Weekly Trademark Review May 27, 2014
    • Abstract: OTC drug, personal care product and nutriotional supplement trademark filings compiled by “The Tan Sheet” from Official Gazette of the U.S. Patent and Trademark Office, Class 3 – Cosmetics and Cleaning Preps; and Class 5 – Pharmaceuticals.
      PubDate: Mon, 02 Jun 2014 00:01:54 -040
  • In Brief: Lornamead Settles On Lice Claims; DASCA Introduced In House; FDA
           Warns Supplement Firms
    • Abstract: Lornamead settles false claims allegations; DASCA bill introduced in House; FDA warns three firms about unapproved drug claims; Actavis expands manufacturing; Valeant defends reputation, Allergan bid; Tom’s Of Maine launches Toddler Training Toothpaste; and FDA to host Nutrition and Supplement Facts labels.
      PubDate: Mon, 02 Jun 2014 00:01:37 -040
  • FDA Recalls For May 28, 2014
    • Abstract: Recalls reported by FDA for OTC drugs, devices, nutritionals and personal care products.
      PubDate: Mon, 02 Jun 2014 00:01:14 -040
  • FDA Faces More Tech Hurdles After Clearing AERs Backlog, And Congress Is
    • Abstract: Congressional scrutiny of FDA’s overall document management challenges is unlikely to let up despite the agency’s clearing of its adverse event reports backlog. Rep.
      PubDate: Mon, 02 Jun 2014 00:00:32 -040
  • EWG Seeks Realistic FDA Review Deadlines In Sunscreen Innovation Act
    • Abstract: While the Environmental Working Group supports the Sunscreen Innovation Act, it would like to see realistic deadlines put in place to accelerate FDA’s review of sunscreen-ingredient time-and-extent applications without including a default mechanism that would grant free market access to certain sunscreen actives when FDA fails to act within allotted timeframes.
      PubDate: Mon, 02 Jun 2014 00:00:21 -040
  • FDA Plans To Rely On Non-U.S. Regulators In Global Drug Quality Initiative
    • Abstract: FDA restructures its staff as it prepares for new U.S.-EU mutual reliance activities to enhance pharmaceutical quality, but it offers few details on upcoming plans.
      PubDate: Mon, 02 Jun 2014 00:00:14 -040
  • Dermatology, Nasal Sprays Among Emerging OTC Switch Categories
    • Abstract: FDA threw the switch floodgates open with the NSURE initiative and it has fueled interest with the recent first-in-class switches of Nasacort and Oxytrol for Women. Likely categories for successful switches include dermatology, nasal sprays in allergy, sleep, migraine relief and cholesterol management.
      PubDate: Mon, 02 Jun 2014 00:00:10 -040
  • Draft Guidance On Developing Drug Names Calls For Simulation Studies
    • Abstract: FDA’s draft guidance on developing proprietary drug names recommends steps to evaluate a proposed name, including testing names with health care professionals. The draft notes that OTC “brand name extensions have posed problems when the same root proprietary name is used for multiple products.”
      PubDate: Mon, 02 Jun 2014 00:00:05 -040
  • Fears Of Too Many OTC Choices Should Not Restrict Switches, Stakeholders
    • Abstract: FDA and its advisory committees should not meddle with the free market by potentially limiting Rx-to-OTC switches based on how crowded a self-care category is or by removing “obsolete” ingredients from the market once new, improved treatments become available, stakeholders argue.
      PubDate: Fri, 30 May 2014 00:02:00 -040
  • With OTC Cialis Rights, Sanofi Launches Latest Salvo
           In Consumer Sector Battle
    • Abstract: Sanofi gains rights from Eli Lilly & Co. to apply for OTC approval of Cialis in the U.S., Europe, Canada and Australia. Launching the first OTC product indicated for erectile dysfunction would mark another milestone in Sanofi CEO Chris Viebacher’s mission to move the firm into the neighborhood of global OTC leaders.
      PubDate: Wed, 28 May 2014 12:50:00 -040
  • FDA Almost Ready To Close Door On Rx Versions Of
    • Abstract: FDA drug center Director Janet Woodcock says the agency “concluded there is no genuine and substantial issues that precludes the withdrawal” of approval of ANDAs for generic Rx polyethylene glycol 3350 products. But FDA is allowing firms with the ANDAs 60 days to again argue their positions.
      PubDate: Wed, 28 May 2014 00:00:03 -040
  • Weekly Trademark Review May 20, 2014
    • Abstract: OTC drug, personal care product and nutriotional supplement trademark filings compiled by “The Tan Sheet” from Official Gazette of the U.S. Patent and Trademark Office, Class 3 – Cosmetics and Cleaning Preps; and Class 5 – Pharmaceuticals.
      PubDate: Mon, 26 May 2014 00:01:59 -040
  • House, Senate Appropriators Set FDA Spending Below White House Request
    • Abstract: Both the House and Senate Appropriations subcommittee set agency funding about $300 million less than President Obama requested. The Senate bill adds $1.5 million to the Health and Human Services Department Office of Inspector General specifically for FDA oversight activities.
      PubDate: Mon, 26 May 2014 00:01:55 -040
  • In Brief: FTC, FDA Enforcement; Insider Trading On NBTY Sale; Comment
           Period On Label Changes
    • Abstract: FTC says Pure Green Coffee perks false claims; NBTY shareholder settles insider trading case; scientific citations trigger warning letter; supplement labels must detail plant source; scientific citations trigger warning; and more news In Brief.
      PubDate: Mon, 26 May 2014 00:01:49 -040
  • Minor OTC Monograph, Labeling Changes Face Major Hurdles, Firms Tell FDA
    • Abstract: In comments on updating the OTC monograph system, P&G says “product innovations may be incremental and the existing pathways are not optimal approaches for manufacturers to request approval of minor changes,” and GSK urges FDA to develop mechanisms “to encourage innovation … by allowing the introduction of certain types of changes to products containing ingredients known to be safe and effective.”
      PubDate: Mon, 26 May 2014 00:01:44 -040
  • Consumer Reports Sunscreen Complaints Look Cloudy To Trade Groups
    • Abstract: Of the 20 water-resistant sunscreens Consumer Reports tested, two provide the full SPF promised after subjects soaked in water and two claiming broad spectrum coverage failed required UVA testing. Industry trade groups complain the report is inaccurate and lacks crucial details about how the tests were conducted.
      PubDate: Mon, 26 May 2014 00:01:39 -040
  • Determining E-Cigarettes’ Regulated Future' A Matter Of More
           Time, Stakeholders And Consumers Say
    • Abstract: U.K. researchers say more time is needed to confirm whether e-cigarettes have efficacy in smoking cessation and harm reduction. Businesses and consumers, meanwhile, are deluging FDA with requests for more time to comment on the agency proposal to regulate the industry.
      PubDate: Mon, 26 May 2014 00:01:33 -040
  • OTC Monographs Finalized In 81% Of Categories
    • Abstract: Of the 52 monograph categories in FDA’s OTC Drug Review, 81% have a final monograph, including negative, according to CHPA’s latest summary.
      PubDate: Mon, 26 May 2014 00:01:29 -040
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