GAO Report Asks For Improvement in FDA Recall Procedures
Food recalls are a vital mechanism in preserving the health of citizens across the country. Even with modern advances in technology and food safety, foodborne illnesses still happen, and they can even lead to widespread outbreaks if not kept in check. However, a new report out of the Government Accountability Office demonstrates that we might… read more
FDA Evaluates Hip Implant Safety Issues Affecting 500,000 Americans
Recently, the news has been filled with stories of individuals who have been forced to suffer because their metal-on-metal hip implants failed. This failure has been happening at rates far greater than would be acceptable to the medical community, and the problem became so rampant that recalls were issued. Now, the Food and Drug Administration… read more
Eliquis Approval Delayed Until More Drug Trial Information is Given
A blood thinner that could benefit those suffering from a certain heart condition has had its approval delayed for the time being by the Food and Drug Administration. The drug in question is Eliquis, which is jointly produced by Pfizer and Bristol-Myers Squibb. The drug aims to reduce the risk of blood clots which lead… read more
Report Shows Kids’ ADHD Meds On The Rise While Antibiotics Fall
A new report from the Food and Drug Administration is causing some to rethink the way that certain medications are given to children. The report, which was published in a journal known as Pediatrics, looked at the number of prescriptions that were issued to children since 2002, a ten year timespan. What the FDA found… read more
Genotoxicity Testing Gets New Guidance From FDA
The Food and Drug Administration is offering new guidance that pharmaceutical makers will be required to follow in order to get their items approved for use. The new guidance is labeled as Genotoxicity Testing and Data Interpretation for Pharmaceuticals. It will replace two previous guidances called S2B Genotoxicity, a Standard Battery for Genotoxicity Testing of… read more
FDA Worried About Efficacy and Safety of Carfilzomib Cancer Treatment
The Food and Drug Administration has expressed concerns that a drug seeking approval might be more trouble than it’s worth. The drug being considered for approval is known as carfilzomib. Its makers, Onyx Pharmaceuticals, were hoping that they could get the drug approved for the treatment of multiple myeloma, a rare type of cancer that… read more
Outlook Not Good on FDA Approval of Semuloparin Blood Thinner
The Food and Drug Administration needs more information before they can approve a new drug for the prevention of blood clots in individuals who are in the process of undergoing chemotherapy. The drug being considered is a blood thinner known as semuloparin. Produced by the Paris-based Sanofi, it was hoped by the company that the… read more
FDA To Consider Approval of Laser Labeling For Produce
If you’ve been to the grocery store to buy produce, you’ve no doubt come across the stickers that are placed on each item to designate what kind of fruit it is. But if a new report is any indication, those stickers could soon become a thing of the past. The Food and Drug Administration has… read more
FDA Proposes New Labels To Be Placed on Drugs With Albumin
The Food and Drug Administration is planning on adding new warning labels to certain types of drugs. The comment period has opened up on the FDA’s proposed plans to mandate various labeling requirements on drugs that contain what’s known as albumin. Any drugs which have albumin, which is derived from plasma, will now have to… read more
FDA Calls Out Deficiencies in Sapien Heart Valve Clinical Trials
A new medical device is facing a potential hurdle following a Food and Drug Administration review that called into question the safety of the item. The product in question is the Sapien heart valve manufactured by Edwards Lifesciences Corporation. The Sapien is intended to be used as an alternative to surgery in order to correct… read more
Reports of Adverse Drug Reactions Rise From Previous Levels
Adverse reactions from drugs are on the rise. According to a new report from the Institute for Safe Medication Practice’s Quarterwatch surveillance program, 179,855 reports came flooding in to the Food and Drug Administration regarding serious or fatal reactions to drugs last year. This is a marked increase of 9.4% from the previous year, when… read more
FDA Panel Advises Against Xarelto Approval
Going against the opinion of one of the Food and Drug Administration’s drug reviewers, an advisory panel opted to vote against the approval of a potential blood thinner medication. The drug in question is called Xarelto (rivaroxaban). Already on the market for a couple other conditions, its maker was hoping to gain approval to to… read more