Does FDA regulate social media?
The FDA encourages the use of social media technologies to enhance communication, collaboration, and information exchange in support of FDA’s mission to protect and promote public health. The FDA encourages employees to use social media to share information that may benefit the public health.
Who should respond to unsolicited requests for off label use?
1. If a firm chooses to respond to public unsolicited requests for off-label information, the firm should respond only when the request pertains specifically to its own named product (and is not solely about a competitor’s product).
Can you advertise non FDA approved products?
No. In most cases, federal law does not allow the FDA to require that drug companies submit ads for approval before the ads are used.
What is off label use of a medical device?
Off label use as applied to medical devices is the application of the device for a purpose that is not included as an indication in the FDA and EC approved device labeling. Such applications are also called unapproved or new uses.
Can I use FDA logo?
The FDA logo is only for official use of the U.S. Food and Drug Administration and not for use on private sector materials. Unauthorized use of the logo may violate federal law. To view the full FDA Logo Policy as well as the primary logo colors and images of the logo, please visit the FDA’s website.
What is Opdp?
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.
Can doctors prescribe off label?
Off-label prescribing is when a physician gives you a drug that the U.S. Food and Drug Administration (FDA) has approved to treat a condition different than your condition. This practice is legal and common. In fact, one in five prescriptions written today are for off-label use.
What is a reprint carrier?
The reprint carrier — the folder or binder in which the reprint is inserted — was “false or misleading because it presents unsubstantiated superiority claims and overstates the efficacy of Taxotere,” according to the FDA.
Do drug commercials have to list side effects?
The long list of side effects is mandatory, since the FDA requires ads to include an assessment of both the benefits and risks of the products, including all possible side effects.
Can doctors use devices off-label?
Background – Practice of Medicine 1 The government has long recognized that physicians may prescribe or administer any legally marketed product for an off-label use within the practice of medicine.
Can doctors prescribe off-label?