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…focus of global regulators. With the latest updates to the global standard for medical device quality management systems and the proposed new EU Medical Device Regulations, device manufacturers, service providers,…
…runs the blog DrugWonks.com. In his latest post on this issue, Mr. Pitts pillories Rep. DeLauro for her press release and letter. Mr. Pitts’ colleague, Robert Goldberg, also recently posted…
…Act, Proposed SOM Rule, the “ORUSC,” and Distribution Trends (3:20 – 4:00 p.m.) Larry K. Houck and Kenneth Weinstein To RSVP for this program, please email Amy Vasvary at avasvary@hpm.com…
On July 1, 2008, ConsumerLab.com, LLC published a product review titled “Red Yeast Rice Supplements.” Hyman, Phelps & McNamara, P.C. sent an 8-page letter to ConsumerLab on July 17 to…
…15 – 16, 2008, at the Marriott Philadelphia Downtown in Philadelphia, Pennsylvania. A copy of the program is available here. At the event, preeminent members of the nation’s Food and…
…boy!” Last week, RNCentral.com issued its “100 Best Health Care Policy Blogs.” FDA Law Blog joins some other usual suspects in the “Drugs/Pharma” category, including Pharmalot and Eye on FDA. …
…first conference is the Center for Business Intelligence’s Premier Bio/Pharmaceutical Summit on Legal & Regulatory Product Lifecycle Strategies, January 20-21, 2009, at the Hilton Baltimore in Baltimore, Maryland. Information on…
…available at an additional cost. If you are interested in taking advantage ofthis special rate, please contact ACI’s Lisa J. Piccolo at L.Piccolo@americanconference.com. The second conference is the Center for…
…the answers. (You can e-mail me your answers at kkarst@hpm.com) Q1: Who said “So, when you add it all up, this bill will provide regulatory relief, increased competition, economy in government,…
…content. At least one presentation suggested that FDA consider requiring third party websites, such as drugs.com, to contain all FDA-approved product information. And finally, the problems with Sidewiki were addressed…
…Principal Deputy Commissioner Joshua Sharfstein set out their agencies’ priorities for regulation of dietary supplements. For FTC, a continuing priority is advertising substantiation. Mr. Vladeck, in his speech, stressed that it is…
…There are 8 columns of information for each drug listed: “Drug,” “Dosage Form,” “Strength,” “RLD,” “Date of Submission,” “ANDA Approval Date,” “Approval Letter,” and “Exclusivity Decision.” In some cases, the…
By Kurt R. Karst – On September 22, 2010, Novartis Pharmaceuticals Corporation (“Novartis”) filed a Complaint in the U.S. District Court for the District of Columbia challenging FDA’s September 14th…
By Jennifer B. Davis – On September 20, 2010, the Health Resources and Services Administration (“HRSA”) issued two Advanced Notices of Proposed Rulemaking and Requests for Comment (here and here) announcing…
…reviews were completed within 100 days, with an average review time of 62 days (median 51). Since 2007, however, only 4 of 13 applications were reviewed in less than 100…