Table of Contents
What is a drug PI?
In the United States, labelling for the healthcare practitioner is called “Prescribing Information” (PI), and labelling for patients and/or caregivers includes “Medication Guides”, “Patient Package Inserts”, and “Instructions for Use”.
What is PLR format?
Definitions for this presentation: • “PLR format” refers to labeling that meets the requirements at 21 CFR 201.56(d) and 201.57. “Old format” (i.e., non-PLR format) refers to labeling that meets the requirements at §§ 201.56(e) and 201.80. “Drug” refers to both human prescription drug and biological products.
What is Opdp submission?
At present, all pharmaceutical advertisements aired or distributed by companies must be submitted to FDA’s Office of Prescription Drug Promotion (OPDP)—formerly known as the Division of Drug Marketing, Advertising and Communications (DDMAC).
What is Opdp in pharma?
The Office of Prescription Drug Promotion (OPDP) has an active research program designed to investigate applied and theoretical issues of relevance to direct-to-consumer (DTC) and healthcare provider-directed promotional prescription drug materials.
What information is found on a drug label?
All prescription medicine containers include information on the label including the patient’s name, the name of the medicine, dosage and instructions on how often to take the medicine. More detailed printed information about the medication is usually provided by the pharmacy when prescription medicine is dispensed.
Which drug information resource provides compatibility information on parenteral medications?
Handbook on Injectable Drugs American Society of Health-System Pharmacists®, http://www.ashp.org This resource, commonly called Trissel’s, includes information regarding the compatibility and stability of various parenteral medications.
What is a medication guide?
Medication Guides are paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.
How do you label pharmaceutical products?
The FDA Regulations require the following information to appear in the drug labelling materials accompanying all drug products:
- Product Name.
- Dosage Form and Strength.
- Pharmacologic Category.
- Formulation/Composition.
- Indication(s)
- Dosage and Mode of Administration.
How does a manufacturer obtain information about drugs and their side effects?
Prescription drug information on side effects is available on FDA’s Drugs@FDA database and FDA’s FDALabel database. For over-the-counter drugs, read the Drug Facts Label.
What is the role of Opdp and how do they regulate the labeling of prescription drugs?
OPDP works to protect the public health by ensuring that all prescription drug promotional labeling and advertising directed to health care professionals and consumers is truthful, balanced, and not misleading.
What is ISI FDA?
Important Safety Information (ISI), must include the benefits and risks that a drug may have. For broadcast, this information is displayed either verbally or via on-screen text, and within display ad units, this information is included directly within the creative.
What information does a drug label contain Select all that apply?
A drug label identifies the brand and generic names of the drug, drug dosage, expiration date, and special drug warnings. It does not contain the client’s social security number.