- Safety & Recalls
- Regulatory Updates
- Drug Coverage
- COPD
- Cardiovascular
- Obstetrics-Gynecology & Women's Health
- Ophthalmology
- Clinical Pharmacology
- Pediatrics
- Urology
- Pharmacy
- Idiopathic Pulmonary Fibrosis
- Diabetes and Endocrinology
- Allergy, Immunology, and ENT
- Musculoskeletal/Rheumatology
- Respiratory
- Psychiatry and Behavioral Health
- Dermatology
- Oncology
FDA releases draft of guidance on drug-safety issues
The FDA's Center for Drug Evaluation and Research released a new draft guidance on how it develops and classifies drug-safety issues.
The FDA’s Center for Drug Evaluation and Research (CDER) released a new draft guidance on how it develops and classifies drug-safety issues.
The guidance, Drug Safety Information – FDA’s Communication to the Public, describes how CDER communicates emerging drug-safety information.
“In recent years, CDER has begun making information on potential drug risks available to the public earlier – often while the Center is evaluating safety data and determining whether any regulatory action is warranted,” according to a statement from CDER.
The guidance indicated that post-marketing safety issues will be tracked by CDER if they have the potential to lead to:
Withdrawal of FDA approval of a drug; limitations on a use in a specific population or subpopulation.
Additions or modifications to the Warnings and Precautions or Indications sections of the labeling Medication Guide, or other patient package insert.
Other risks.
In addition to the methods FDA already uses to communicate drug-safety issues, the agency is exploring: concise advisories and other Internet postings; more detailed short articles; articles in trade and professional journals; and a standardized, 1-document solution for patient medication information.
CDER also further clarified its Drug Safety Communication, a tool used to communicate important safety information about marketed drugs.
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.
