Fda
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FDA Plans to Regulate Laboratory Developed Tests; Many Questions Remain...
Jul 27, 2010By Jamie K. Wolszon & Jeffrey N. Gibbs – FDA officials, at a July 19-20, 2010 workshop , stated that the agency intends to end the “exercise enforcement” authority over some laboratory-developed tests (“LDTs”). Put more plainly, FDA now plans to regulate some... by fdalawblog.net | related posts
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DTC Tests Face Scrutiny at FDA, by GAO, and Congress
Jul 27, 2010DTC Tests Face Scrutiny at FDA, by GAO, and CongressLast week produced a flurry of activity at the FDA and before Congress relating to regulation of field of DTC genetic tests. Here is a summary: At the FDA: The FDA sent out additional letters to fourteen more DTC companies, stating that the companies’... by predicter.blogspot.com | related posts
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NRDC sues FDA for 30 year delay in regulating antimicrobials.
Jul 27, 2010Today NRDC sued the FDA, again , this time because the Agency has yet to finalize a document 32 years in the making that would regulate the use of antimicrobial chemicals in hand soaps and body washes. Today’s lawsuit asks the court to impose a strict deadline for FDA to... by switchboard.nrdc.org | related posts
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FDA and FCC To Partner on Telehealth Innovation and Implementation –...
Jul 27, 2010FDA and FCC To Partner on Telehealth Innovation and Implementation –...As technology rolls on and with the various areas of safety, devices and drugs we are living with today, the FDA might just in fact become the “most connected” federal agency as much of the work and research being done today that falls under the jurisdiction of the FDA... by ducknetweb.blogspot.com | related posts
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FDA Clears AirStrip RPM for CRITICAL CARE & CARDIOLOGY Remote Patient...
Jul 27, 2010FDA Clears AirStrip RPM for CRITICAL CARE & CARDIOLOGY Remote Patient Monitoring Solutions AirStrip RPM delivers unprecedented ability to improve patient safety through monitoring acute care settings via smartphones PR Newswire — July 27, 2010 SAN ANTONIO, July 27 /PRNewswire/... by indianweb2.com | related posts
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Partnerships Asia Pacific Session Spotlight: FDA Updates: Ensuring...
Jul 27, 2010Each week leading up to Partnerships in Clinical Trials Asia Pacific , we'll be highlighting a session from the upcoming conference. It will take place October 5-7, 2010, in Singapore. For more information, visit our webpage to download the brochure . Featured Session: FDA Updates: Ensuring... by partnershipswithcros.blogspot.com | related posts
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Microsoft Partners With PPD To Provide FDA Risk Evaluation and Mitigation...
Jul 27, 2010Biopharmaceutical companies will have a solution to assess risk and track information as submitted from patients, doctors, and pharmacies participating in various research project. The FDA with all submissions requires risk assessment and in short this is a software program to allow for those... by ducknetweb.blogspot.com | related posts
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FDA Refers Avandia Panel Conflict Question to HHS
Jul 27, 2010Federal drug regulators have referred a potential conflict-of-interest problem on an Avandia advisory panel to the inspector general’s office at the Department of Health and Human Services’ (HHS). Earlier this month, the sharply divided Food & Drug Administration (FDA) panel recommended that... by newsinferno.com | related posts
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FDA Advances in Social Media - What's it Mean for Industry?
Jul 27, 2010Greetings from the 6 th Annual PR & Communications ExL Pharma Summit being held in the headquarters of Pfizer in New York, yesterday and today. One of the highlights of the two-day meeting occurred this morning when CDER's head of public affairs provided attendees with insights into the... by eyeonfda.com | related posts
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Sanofi-Aventis Sues The FDA Over Generic Lovenox
Jul 27, 2010Sanofi-Aventis Sues The FDA Over Generic LovenoxStunned by the FDA approval of a generic version of its best-selling Lovenox blood thinner, Sanofi-Aventis has filed a lawsuit in federal court, charging the agency with exceeding its authority, and acted arbitrarily and capriciously in granting Momenta Pharmaceuticals the right to market a drug... by pharmalot.com | related posts
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FDA Opioid REMS Advisory Panel Focus on CME for Improving Practice
Jul 27, 2010FDA Opioid REMS Advisory Panel Focus on CME for Improving Practice(DSaRM), hosted by the Food and Drug Administration (FDA) and the Center for Drug Evaluation and Research (CDER). Dr. Kopelow spoke to participants by highlighting how continuing medical education (CME) would be an extremely useful and tremendous tool to help educate physicians and health care... by policymed.com | related posts
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The Other Shoe Drops . . . . Sanofi Sues FDA Over Generic LOVENOX...
Jul 27, 2010By Kurt R. Karst – As we thought might happen , Sanofi-aventis U.S. L.L.C. (“Sanofi”) sued FDA over the Agency’s July 23, 2010 approval of Sandoz Inc.’s (“Sandoz’s”) ANDA No. 77-857 for a generic version of Sanofi’s blockbuster anti-coagulant drug LOVENOX (enoxaparin... by fdalawblog.net | related posts
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