Posts tagged with: "fda"
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16 Apr 2014, 7:00 am by Danielle Teagarden
A couple of months back in a guest post, our good friend and fellow beer attorney Brook Bristow provided a thoughtful overview of proposed regulations from FDA. The potential regs would affect brewers’ ability to sell their spent grain to farmers, requiring strict handling, testing, and record-keeping processes. Since the post, the Brewers Association and the farming industry have spoken out against the regulations. They’ve observed, the cost of compliance could turn brewers away from… [read post]
25 Jan 2010, 8:36 am by Hopkins
A jury in Oregon state court delivered a verdict of $5.5 million against I-Flow Corporation for causing devastating, permanent injuries to Matthew Beale by promoting the use of I-Flow pain pumps in joints. The pain pumps, like those used on Mr. Beale, were promoted by manufacturers including Breg, Stryker, McKinley and I-Flow to physicians for use after joint surgeries. The theory was insertion of a delivery system that would place pain medicine at the area of surgery would allow for greater pain… [read post]
17 Oct 2011, 6:03 pm by Bryan Fears
In the last three years, more than 3,000 patients have experienced complications after a transvaginal mesh procedure. The transvaginal mesh operation was designed as a surgical remedy to pelvic organ prolapse, a not uncommon side effect of a childbirth or hysterectomy. However, of the more than 100,000 procedures that occur annually, a significant number have resulted in such painful side effects as infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems.   The… [read post]
21 Apr 2011, 9:07 am by Food Liability Attorney
Here is a link to my article, "FDA's Reportable Food Registry Profoundly Impacts Litigation and the Food Industry," posted this week by the American Bar Association's Litigation Section (Products Liability). The article is a follow-on to lively discussions over the litigation impacts of the federal Reportable Food Registry ("RFR") at the ABA’s recent Food & Supplements CLE at Coca-Cola World Headquarters in Atlanta. The RFR was created by Congress as part of the Food and Drug Administration… [read post]
9 Jun 2011, 3:29 pm by Ken Odza, former Stoel Rives attorney
Next Wednesday at the ACI Food Regulatory Summit in Chicago I'll be presenting a talk entitled "Curtailing Downstream Liability Arising Out of On-Site Inspections: How to Prepare and What to Do Should Government Come Knocking." My slide-deck can be linked here. Topics that I plan to cover include: FDA's plan to increase frequency of inspections and how it plans to do it How to be prepared for FDA's greatly expanded records access authority How to avoid new fees that will be imposed by… [read post]
20 Nov 2009, 6:41 am by Greenberg & Bederman
Let’s say for the sake of argument that we decided to get into the car wax business. Let us further say that we spent millions of dollars on an advertising campaign in which we claimed that not only would our wax make your car extremely shiny, but would also make it run better. If we ran ads making this claim in newspapers, on television, the radio and the internet, we would be in serious trouble, regardless of the accuracy of our claims about the ability of our wax to make cars shine. The… [read post]
8 May 2013, 6:00 am by Brendan Turley
Index to Drug-Specific Information- if a drug has been the subject of review or safety advisory, you can find it on this alphabetical index MedWatch Alerts- you can sign up to receive email alerts from Medwatch, an agency that reports bad drug events to the FDA Daily Med- provides labels to pharmaceuticals to consumers and professionals Drugs@FDA-this is a search engine that allows you to look up pharmaceuticals by name or active ingredient FDA Drug Safety Podcasts FDA Consumer Health Information-… [read post]
13 Jun 2013, 6:17 pm by Antoinette Konski
In a remarkable move, the Food and Drug Administration recently indicated that it plans to take new steps to regulate laboratory-developed tests (“LDTs”). FDA Commissioner Margaret Hamburg made the significant announcement during a speech on June 2, 2013, at an annual meeting of the American Society of Clinical Oncology. Historically, FDA has exercised enforcement discretion when regulating LDTs and generally exempted them from regulatory requirements because LDTs have often… [read post]
13 Jun 2013, 6:17 pm by Antoinette Konski
Guest Post By David L. Rosen, Nathan A. Beaver and Jennifer M. Forde   In a remarkable move, the Food and Drug Administration recently indicated that it plans to take new steps to regulate laboratory-developed tests (“LDTs”). FDA Commissioner Margaret Hamburg made the significant announcement during a speech on June 2, 2013, at an annual meeting of the American Society of Clinical Oncology. Historically, FDA has exercised enforcement discretion when regulating LDTs… [read post]
16 Jun 2013, 4:36 pm by Antoinette Konski
Guest Post By Jennifer M. Forde, Nathan A. Beaver and David L. Rosen In a resounding manner, members of the medical device industry recently filed comments reacting to the Food and Drug Administration’s proposed rule to strengthen its oversight of overseas clinical studies of medical devices. The proposed rule would replace the current practice, which does not require review by an independent ethics committee. Currently, FDA accepts data from clinical trials conducted outside the… [read post]
6 Jan 2013, 6:02 pm by Antoinette Konski
The Food and Drug Administration (FDA) recently issued a guidance document related to the conduct of clinical trials to support approval of human drugs and biological products “Draft Guidance for Industry: Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products” (“Guidance Document”). The document is intended to provide guidance for enrichment strategies that can be used in clinical trials intended to support effectiveness and… [read post]
16 Jun 2013, 4:36 pm by Antoinette Konski
Guest Post By Jennifer M. Forde, Nathan A. Beaver and David L. Rosen In a resounding manner, members of the medical device industry recently filed comments reacting to the Food and Drug Administration’s proposed rule to strengthen its oversight of overseas clinical studies of medical devices. The proposed rule would replace the current practice, which does not require review by an independent ethics committee. Currently, FDA accepts data from clinical trials conducted outside the… [read post]
28 Oct 2011, 6:16 pm by Tom Lamb
Will NuvaRing Safety Study Findings Be Addressed By FDA Advisory Committees At Joint Meeting In December 2011? (Posted by Tom Lamb at DrugInjuryWatch.com) On October 27, 2011 the FDA released its new drug-safety study report, "Combined Hormonal Contraceptives (CHCs) and the Risk of Cardiovascular Disease Endpoints", which included the NuvaRing (etonogestrel / estradiol vaginal ring) -- referred to as "ETON" in this 2011 FDA study report. This FDA study was intended to determine whether the… [read post]
30 Sep 2011, 1:33 pm by Brenda Fulmer
Over the past decade, the Food & Drug Administration has made great efforts to provide improved safety information to patients and consumers. The FDA web site includes a number of helpful materials: warning labels, podcasts white papers prepared for scientific panels that summarize complex medical and scientific data Power Point presentations made to scientists and FDA employees “Dear Doctor” letters informing physicians of changes in drug labeling DDMAC enforcement letters for violations of… [read post]
30 Sep 2011, 1:33 pm by Brenda Fulmer
Over the past decade, the Food & Drug Administration has made great efforts to provide improved safety information to patients and consumers. The FDA web site includes a number of helpful materials: warning labels, podcasts white papers prepared for scientific panels that summarize complex medical and scientific data Power Point presentations made to scientists and FDA employees “Dear Doctor” letters informing physicians of changes in drug labeling DDMAC enforcement letters for violations of… [read post]
2 Nov 2011, 1:47 pm by Tom Lamb
Given These New FDA Drug Safety Findings About Ortho Evra, What Will Two Advisory Committees Do At Joint Meeting On December 9, 2011? (Posted by Tom Lamb at DrugInjuryWatch.com) On October 27, 2011 the FDA released its new drug-safety study report, "Combined Hormonal Contraceptives (CHCs) and the Risk of Cardiovascular Disease Endpoints", which included the Ortho Evra birth control skin patch (norelgestromin/ethinyl estradiol transdermal patch) -- referred to as "NGMN" in this 2011 FDA study… [read post]
31 Oct 2011, 1:39 pm by Tom Lamb
Safety Study Findings About Drospirenone (DRSP) Birth Control Pills Will Be On The Agenda For FDA Advisory Committees At Joint Meeting In December 2011 (Posted by Tom Lamb at DrugInjuryWatch.com) On October 27, 2011 the FDA released its new drug-safety study report, "Combined Hormonal Contraceptives (CHCs) and the Risk of Cardiovascular Disease Endpoints", which included the popular birth control pills YAZ, Yasmin, and Ocella. This FDA study was intended to determine whether drospirenone… [read post]
27 Jan 2014, 1:00 am by thehealthlawfirm
By Lance O. Leider, J.D., The Health Law Firm It is estimated there are 3,000 compounding pharmacies in the United States, 14 of which have signed up to be regulated by the U.S. Food and Drug Administration (FDA) under the Drug Quality and Security Act. On January 8, 2014, the commissioner of the FDA sent thousands of letters to hospitals and other medical providers that may buy medicines from the compounding pharmacies. The letters urged providers to encourage compounding pharmacies to register as… [read post]
13 Dec 2013, 1:00 am by thehealthlawfirm
By Lance O. Leider, J.D., The Health Law Firm On November 18, 2013, the United States Senate voted to increase federal oversight of compounding pharmacies that produce large volumes of mixed drugs. This bill comes in the wake of last year’s meningitis outbreak stemming from unsanitary conditions at the New England Compounding Center (NECC). Click here to read a previous blog on the meningitis outbreak. This bill does not give the U.S. Food and Drug Administration (FDA) absolute authority over… [read post]
10 May 2011, 3:24 pm by Ken Odza, former Stoel Rives attorney
I authored the following article that appeared in the April 29, 2011 issue of Food Chemical News: As the clock ticks on the FDA’s 24-hour deadline to report to the FDA’s Reportable Food Registry, a food retailer, manufacturer or supplier is forced to make snap decisions that can profoundly impact business and litigation. Once a report is submitted, the FDA promptly alerts customers and suppliers of the "reasonable probability" that the product will result in "adverse health consequences or… [read post]