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- Produce safety plan issued by FDA.(Washington)(Food and Drug Administration)
- FDA released its 2004 Produce Safety Action Plan, "Produce Safety From Production to Consumption: 2004 Action Plan to Minimize Foodborne Illness Associated with Fresh Produce Consumption." The plan supercedes the agency's proposed action pl FDA released its 2004 Produce Safety Action Plan, "Produce Safety From...
- Research articles 2004-10-25
- FDA Amends Postmarket Program for Medical Devices
- The U.S. Food and Drug Administration FDA announced on November 10 its action plan for strengthening its monitoring of the safety of medical devices after they reach the marketplace. "Many of today's medical devices are smaller and more complex thaThe U.S. Food and Drug Administration FDA announced on November 10...
- Research articles 2007-01-01
- Wolters Kluwer Health Unveils Integrated MedFacts Module for Medi-Span; Significant Enhancement Brings FDA-approved and 'Action Plan'-compliant Medication Information to Consumers and Their Caregivers
- PHILADELPHIA -- Wolters Kluwer Health WKHealth, the leading drug and health information provider, today unveiled its new Integrated MedFacts Module for the Medi-Span product line, which will provide pharmacists and other healthcare professionals with the tools they need to help consumers understand their medications.
- Research articles 2005-08-29
- FDA's action plan for acrylamide. (Regulatory Issues).
- If you're not a chemist, chances are good you hadn't heard of acrylamide before April, 2002, when the Swedish National Food Administration reported its existence in a variety of fried and oven-baked foods. The Swedish research indicates that acrylami If you're not a chemist, chances are...
- Research articles 2002-11-01
- FDA Outlines Five-Part Strategic Action Plan to "Protect and Advance America's Health"
- The Food and Drug Administration FDA five-part strategic action plan provides pharmaceutical companies with insights into the FDA's targeted goals and objectives. Pharmaceutical companies should monitor the developments related to the FDA's strategic plan initiative, particularly with respect to guidance documents. In addition, the FDA's risk based approach to regulations...
- White papers 2003-08-01
Additional Resources
- Judge: Bush White House Wanted Right-to-Lifers on FDA's Contraception Panel
- A federal court ruling on Teva's Plan B "morning after" contraceptive reveals how the Bush White House corrupted the internal operations of the FDA, encouraged decisions not based on science, and led to months-long delays in approvals process. Judge Edward Korman's ruling makes Plan B pictured available...
- Blog posts 2009-03-24
- FDA unveils strategic plan to protect and advance America's health.(Washington)
- FDA outlined how it is taking new steps to protect and advance public health for America in a comprehensive five-part strategic action plan entitled "Protecting and Advancing America's Health: A Strategic Action Plan for the 21st Century." FDA outlined how it is taking new steps...
- Research articles 2003-08-25
- FDA warns Jones Pharma on promotion
- A Jones Pharma Levoxyl levothyroxine advertisement in a program and abstract book from the September 1999 American Thyroid Association annual meeting drew a January 21 FDA Warning Letter because it was identical to an earlier violative ad in the September 1998 Pharmacist magazine. Both ads suggested that Levoxyl is interchangeable...
- Research articles 2000-03-01
- HHS Preparing to Open FDA Offices in China, India, Europe, and Latin America This Year
- Globalization of the Agency a Key Part of Import Safety Action Plan to Enhance Product Safety WASHINGTON -- The U.S. Department of Health and Human Services will send the first U.S. Food and Drug Administration FDA staff to China, India, Europe, and Latin America before the end of 2008,...
- Research articles 2008-10-16
- Packaging coalition to fight FDA regulations.(Plan Of Action Set)
- In a meeting last week in Washington, D.C., executives of the packaging coalition fighting the U.S. Food and Drug Administration's FDA proposed food packaging regulations developed a plan of action to include visiting key senators and representa In a meeting last week in...
- Research articles 2003-08-16
- Eli Lilly Q2 2007 Earnings Call Transcript
- Question-and-Answer SessionOperator Operator Instructions And our first question comes from the line of James Kelly of Goldman Sachs. Please go ahead. James Kelly - Goldman Sachs Thank you and good morning. My question relates to Zyprexa and the depot formulation, and thank you for the additional data in Canada...
- Earnings calls 2007-07-24
- Marsam facility on track with FDA corrections
- Schein Pharmaceutical says the FDA has agreed to its voluntary approach to correcting GMP deficiencies at its Marsam Pharmaceuticals' manufacturing facility. Schein does not expect firther regulatory enforcement action at Marsam relating to the inspection. "I believe that the company now has closure on this inspection and has a clear...
- Research articles 2000-05-01
- FDA doubles effort on confusing drug names
- President Clinton's call in February for new FDA action against look-alike, soundalike drug names and packaging is rooted in an FDA plan to double the resources presently applied to monitoring adverse drug event data for medication errors caused by these cases, according to the agency. Until new resources become available,...
- Research articles 2000-04-01
- GRAPEVINE: News About People
- Institute of Food Technologists announced Stephanie Smith as its director of science and government relations. Smith's most recent experience is with the National Confectioners Association and FDA. During her tenure with FDA she coordinated the interagency Egg Safety Action Plan. Smith also worked on the staff of Sen. Susan Collins...
- Research articles 2000-05-29
- NPLAC: FDA's Plan B Decision is Bad Medicine for Women and Children; Good News for Sexual Predators
- WASHINGTON, Aug. 24 /U.S. Newswire/ -- Kimberly Zenarolla, executive vice president of the National Pro-Life Action Center NPLAC -- the uncompromising voice of pro-life America on Capitol Hill -- has issued the following statement regarding today's deciWASHINGTON, Aug. 24 /U.S. Newswire/ -- Kimberly Zenarolla, executive vice president of the National...
- Research articles 2006-08-24
- Morton Grove Pharmaceuticals
- Morton Grove Pharmaceuticals, Morton Grove, IL, Jan. 14 Chicago. FDA cited Morton Grove for lack of a "documented action plan, conclusion or corrective action" in instances of stability failures in two lots of topical Clindamycin phosphate and one of topical Tretinoin solution. The stability failure investigation for Myphetene...
- Research articles 2000-03-13
- Alcon Incorporated Q3 2007 Earnings Call Transcript
- Question-and-Answer Session Operator Thank you. [Operator Instruction] please stand by for your first question. Your first question will be from the line of Peter Bye of Jefferies & Co. Peter Bye – Jefferies & Co Thanks and good morning. I apologize if you’ve already...
- Earnings calls 2007-10-25
- ImClone Systems Inc. Q3 2007 Earnings Call Transcript
- Question-and-Answer SessionOperator [Operator Instructions]. Your first question comes from May-Kin Ho of Goldman Sachs. May-Kin Ho - Goldman Sachs Hi. I guess, I wanted to ask question about really how your payment from Bristol would be recognized and how we should going forward project out...
- Earnings calls 2007-10-25
- BioMed News Bytes: Dyax, Human Genome Sciences, Aldagen
- Mike Havrilla submits:The BioMedReports.com FDA Calendar service includes a database with over 400 entries of (1) pending new drug, biological agent, or medical device new product decisions at the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings); (2) pending new submissions to the FDA; (3) pending complete response...
- External links 2009-10-29
- Dyax Corp. Q2 2009 Earnings Call Transcript
- Question-and-Answer SessionOperator Operator Instructions Our first question will come from the line of Mark Monane from Needham; please proceed. Mark Monane - Needham Good morning and greeting from New York City. Thanks for the nice review of the programs. A question for you first on the commercial nature; could...
- Earnings calls 2009-07-22
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