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26 Aug 2008, 3:28 pm
Inspection Found Sandoz  Failed To Properly Validate Manufacturing Process For Metoprolol Succinate ER Tablets (Generic Form Of Toprol XL) Before Distributing Pills (Posted by Tom Lamb at There is yet another apparent quality-control problem in the generic drug manufacturer sector. [read post]
21 Jan 2009, 7:10 am
ISMP QuarterWatch: Cannot "rule out, or state definitively, whether defective digoxin tablets led to hundreds of patient deaths" (Posted by Tom Lamb at On January 15, 2009 The Institute for Safe Medication Practices (ISMP) released QuarterWatch: 2008 Quarter 2, which includes an analysis of how the Digitek recall has been handled by Actavis, the drug maker, and FDA, the regulatory agency, which demonstrates how ineffectual the FDA has become when it… [read post]
11 Sep 2009, 10:33 am
., Parke-Davis, Warner-Lambert, and Pfizer (Posted by Tom Lamb at The Drug Industry Document Archive (DIDA), created by the University of California at  San Francisco (UCSF), contains over 1500 documents, many of which were previously secret and only made public as a result of lawsuits filed against pharmaceutical companies. [read post]
20 May 2008, 9:08 am
Actavis, Mylan, Or The FDA Should Tell Public Their Current Estimate Of How Many Defective Digitek Pills Were Distributed To Pharmacies, And During What Time Period (Posted by Tom Lamb at On May 9, 2008 Actavis North America issued this press release "Digitek ® recall - customer support and frequently asked questions", which looked like it contained some new information about the Digitek recall. [read post]
26 Jun 2009, 1:24 pm
Marshals Seize Drug Products From Caraco's Three Michigan Facilities Due To Continuing Lack Of Quality Controls (Posted by Tom Lamb at On June 25, 2009 the FDA issued a press release, "U.S. [read post]
3 Nov 2008, 5:01 pm
Read What The Attorneys For Diana Levine And Wyeth Argued, And What Questions Were Asked By The Justices Regarding Possible Federal Preemption Of This Drug Injury Case (Posted by Tom Lamb at In the run up to the November 3, 2008 oral arguments in the Wyeth v. [read post]
24 Oct 2007, 2:01 pm
A "Dear Doctor" Letter About Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Associated With Provigil Was Sent In September 2007 (Posted by Tom Lamb at On October 24, 2007 the FDA sent an email alert to inform doctors and other healthcare providers that the drug company Cephalon issued a revised package insert, or label, for Provigil (modafinil) in August 2007. [read post]
4 Jan 2008, 8:33 am
Public Citizen Files Lawsuit Against FDA Seeking "Black Box" Warning About This Painful And Lingering Side Effect (Posted by Tom Lamb at According to a January 3, 2008 Reuters article, "Group sues U.S. in push for new antibiotic warning", the consumer group Public Citizen has filed a lawsuit intended to force the FDA to consider whether stronger warnings should be added to certain antibiotics such as Johnson & Johnson's… [read post]
10 Sep 2008, 9:32 pm
Recall That Bristol-Myers Had Said Decline In Sales Was Reason For Its Decision To Stop Selling Tequin (Posted by Tom Lamb at On September 2, 2008 the FDA issued a Notice entitled "Determination That TEQUIN (Gatifloxacin) Was Withdrawn From Sale for Reasons of Safety or Effectiveness"  which provides (and confirms) the real reason that Bristol-Myers Squibb Co. [read post]
13 Jul 2012, 2:17 pm by Tom Lamb
Greater Risk For Uveitis, Scleritis, And Other Ocular Side Effects According To Two Recent Medical Journal Articles (Posted by Tom Lamb at Fosamax, Boniva, and other osteoporosis medications in the bisphosphonates drug class have been linked to osteonecrosis of the jaw (ONJ) and atypical femur fractures, with both of these side effects getting considerable coverage in the popular press for some years now. [read post]
8 Mar 2012, 2:16 pm by Tom Lamb
Federal Court NuvaRing MDL Bellwether Trial Dates Pushed Back Several Times Previously; Perhaps It Will Be Late 2012 (Posted by Tom Lamb at The first NuvaRing lawsuit has been scheduled to start trial in February 2013 pursuant to In Re: NuvaRing Litigation Case Management Order (CMO) #19. [read post]
4 Aug 2009, 10:02 am
In July 2009 FDA Issues  Updated Guidance For Industry Document Concerning DILI In Premarketing Clinical Evaluation (Posted by Tom Lamb at In July 2009 the FDA issued a Guidance  for Industry document intended for pharmaceutical companies developing new prescription drugs which  explains how certain laboratory measurements obtained in clinical trials can be used to assess the new drug's potential to cause severe… [read post]
6 Aug 2008, 1:40 pm
August 2008 ASA Meeting: Sociologist Donald Light Presents His Paper, "Institutional Foundations of the Vioxx Disaster" (Posted by Tom Lamb at On August 3, 2008, at the American Sociological Association (ASA) annual meeting in Boston, Donald W. [read post]
1 Jul 2009, 1:06 pm
Will Warn About Risk Of Serious Neuropsychiatric Symptoms Including Agitation, Depression, Suicidal Thoughts, And Attempted Suicide (Posted by Tom Lamb at On July 1, 2009 the FDA issued a Public Health Advisory about Chantix (varenicline) as well as Wellbutrin (bupropion) and Zyban (bupropion) which announced that these smoking cessation drugs will be getting a so-called "black-box" warning: ...highlighting the risk of serious neuropsychiatric… [read post]
22 Sep 2010, 1:01 pm by Tom Lamb
Will This September 2010 EMA Committee Meeting Result In A Consensus, Unlike July 2010 FDA Avandia Panel Voting  (Posted by Tom Lamb at _______________________________________________________________________ UPDATE:  FDA Keeps Diabetes Pill on Market; Europe Suspends Sales  (9/23/10, Wall Street Journal) ______________________________________________________________________________ The Committee for Medicinal Products for Human Use… [read post]
25 Sep 2007, 3:00 pm
FDA Post-Marketing Safety Review Adds Liver Problems To Previous Reports Of Kidney Failure Associated With Exjade (Posted by Tom Lamb at In the first edition of FDA Drug Safety Newsletter (Volume 1, Number 1), which was posted on the FDA's web site September 18, 2007, there is an article about the agency's post-marketing safety review of Exjade (deferasirox). [read post]
30 Apr 2012, 1:49 pm by Tom Lamb
While Mediations And Negotiations Continue, The First Scheduled YAZ / Yasmin Trials In Federal And State Courts Are Postponed Indefinitely (Posted by Tom Lamb at In late April 2012 Bayer announced that it has settled lawsuits involving YAZ and Yasmin side effects related to blood clots, namely deep vein thrombosis (DVT) and pulmonary embolism (PE) cases. [read post]
8 May 2007, 8:30 am
Recent Subjects Have Been Drug Recalls Involving IBS Medication Zelnorm And Parkinson's Drug Permax (Posted by Tom Lamb at An April 20, 2007 FDA News item reminded doctors and other health care professionals as well as patients and interested consumers that since February 2007 the FDA has been providing its emerging drug safety information by means of audio broadcasts. [read post]
20 Sep 2007, 3:04 pm
FDA Links Cephalon's Provigil To Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome, And Erythema Multiforme (Posted by Tom Lamb at According to the Fall 2007 FDA Drug Safety Newsletter (Volume 1, Number 1), which was released in mid-September 2007, the FDA has been monitoring cases of serious skin reactions associated with the sleep disorder drug Provigil (modafinil). [read post]