The current form of the PI offers a comprehensive, well-organized monograph.
The FDA is expanding its efforts to expedite the development and review of promising therapies for serious conditions using fast-track, breakthrough-therapy, accelerated approval, and priority-review designations.
Although imperfect, the ACA is a necessary stepping-stone to better healthcare delivery.
Pharmacists can help relieve the financial burden that health care excesses place on American taxpayers.
It's disappointing that new provisions in the Risk Evaluation and Mitigation Strategy program do not directly address pharmacists taking a more active role in patient consultations.
Growing concerns call for a solution that enables the safe removal of
unused or unwanted medications from households in order to prevent
prescription drug abuse, accidental ingestion, and environmental
A significant number of recent products approved by the FDA are new formulations.
Pharmacists should look to Canada for a preview of what pharmacy in the U.S. might look like under health care reform.
As an integral part of the health care system, pharmacists should be involved in reform decisions.
The FDA may request that a sponsor seeking approval of a new drug conduct a postmarketing study.
The research and development (R D) process for a new drug takes an average of 10 to 15 years and involves many discrete steps and activities.
The FDA has broadened the indications for methylphenidate (Concerta) extended-release tablets in doses of 18 mg to 72 mg/day to include adults with attention-deficit hyperactivity disorder (ADHD).
The FDA added a boxed warning to the label of Regranex Gel 0.01% (becaplermin)--a topical cream for treating stubborn leg and foot ulcers in diabetic patients--due to increased risk of death from cancer.
The FDA has acted to require manufacturers of an older class of drugs known as conventional antipsychotics to add boxed warnings to their labeling about an increased risk of death associated with their off-label use to treat behavioral problems in older patients with dementia.
Following positive tests for Burkholderia cepacia, Sage Products has announced a voluntary recall of limited lots of its 2% Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product.
For all the hoopla and noise being made by the two presidential hopefuls over the state of our health care, there is not much talk about life expectancy in the United States compared with that in other countries.
United States marshals seized more than $1.3 million worth of dietary supplements from LG Sciences, LLC, of Brighton, Michigan, because the products contain unapproved food additives and/or new dietary ingredients.
The FDA has issued draft guidelines to aid the development, testing, and manufacture of coronary drug-eluting stents, devices for treating blocked heart arteries...
The FDA has received approval from the U.S. State Department to establish eight full-time permanent FDA positions at U.S. diplomatic posts in the People's Republic of China, pending approval from the Chinese government.
The FDA has identified 25 drugs and biologic products that will be required to submit a proposed Risk Evaluation and Mitigation Strategy (REMS) safety plan by September 21, 2008.
FDA Releases Stent Recommendations The FDA has issued draft guidelines to aid the development, testing, and manufacture of coronary drug-eluting stents, devices for treating blocked heart arteries...
The FDA issued an alert on the safe and correct use of Tussionex Pennkinetic Extended-Release Suspension in response to numerous adverse event reports, including death, associated with the misuse and inappropriate use of the strong cough medication.
Commissioner of Food and Drugs Dr. Andrew C. von Eschenbach last month announced the appointment of Janet Woodcock, MD, as director of the agency's Center for Drug Evaluation and Research(CDER), a position she has held previously.
Citing such false claim as "Treatment Kills all Herpes Viruses WITHOUT having to use conventional drugs or medications" and "Greatest STD Protection Without Condoms" (SlicPlus), the FDA issued Warning Letters to six U.S. companies and one foreign individual for marketing misbranded and unapproved drugs over the Internet.
The FDA announced that Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) have been linked in some cases to adverse reactions, including respiratory failure and death.
Reacting to emerging evidence of a link between the smoking cessation drug Chantix (varenicline) and serious neuropsychiatric symptoms, the FDA issued a Public Health Advisory to alert health care providers, patients, and caregivers to new safety warnings.
The FDA said that it would take enforcement action against companies marketing unapproved injectable colchicine, used to treat gout. Colchicine is a highly toxic drug, especially when given intravenously, and the FDA is aware of 50 reports of adverse events connected to intravenous colchicine, including 23 deaths.
The FDA announced that Baxter Healthcare Corporation has temporarily stopped manufacturing multiple-dose vials of the injectable drug heparin, commonly used before surgery as a blood-thinning agent, due to reports of serious allergic reactions and hypotension in patients who receive high "bolus" doses of the drug.
The Omnibus Budget Reconciliation Act of 1990 (OBRA '90) included mandates for the states to improve understanding of medications by Medicaid beneficiaries for whom they were prescribed and dispensed.
Prison Sentences for Women Who Claimed ALS Cure The FDA Office of Criminal Investigations today announced that a New Jersey woman has been sentenced to 33 months in prison for falsely claiming that she could cure amyotrophic lateral sclerosis (ALS), or Lou Gehrig's disease.
At the behest of the FDA, U.S. Marshals seized more than $300,000 worth of products, including an antifungal product sold as NC Solution, other drugs for human or animal use, dietary supplements, and ingredients of those products.
FDA Halts Marketing of Unapproved Hydrocone Products Companies marketing unapproved drug products containing the narcotic hydrocone must cease or they will be subject to enforcement action, the FDA announced.
FDA Warns Melanotan II Maker The FDA issued a Warning Letter to Brian Manookian, owner of Melanocorp, Inc.
Planning for Flu Outbreaks The FDA issued final recommendations for increasing the supply of safe and effective influenza vaccines for both seasonal and pandemic use.
Online Counterfeit Drug Concerns
FDA Moves to Stop Marketing of Nausea and Vomiting Drug The FDA announced that companies must cease manufacturing and distributing unapproved suppository drug products containing trimethobenzamide hydrochloride.
Xolair to Get Black Box Warning The FDA requested that Genentech, Inc.
FDA to Strengthen Drug Safety The FDA has made recommendations to Congress for the next reauthorization of the Prescription Drug User Fee program that are designed to broaden and upgrade the agency's drug safety program, increase resources for review of television drug advertising, and facilitate more efficient development of safe and effective new medications for the American public.
Warnings Issued Regarding Rituxan Safety Concern in New Patient Population The FDA is alerting health care professionals and patients treated with Rituxan (rituximab), manufactured by Genentech, to reports of an emerging risk of a serious side effect.