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The main purpose of an IFU is to provide “detailed, action-oriented, step-by-step written and visual instructions in a patient-friendly manner,” the agency said. Read More
Approximately half of children and adults with the condition go on to experience fibrosis, cirrhosis or liver transplant within three years of the disease’s onset. Read More
The UK’s Advertising Standards Authority (ASA) — the ad industry’s self-regulatory organization— warned Sanofi for using an Instagram influencer to market its Phenergan Night Time insomnia drug. Read More
The Trump administration is expected to appeal Monday’s ruling by a federal court in Washington, D.C., blocking the HHS rule to require drugmakers to disclose drug prices in their TV ads. Read More
Australia’s Therapeutic Goods Administration (TGA) has updated its guidance on GMP clearance regulations for overseas manufacturing facilities, clarifying the agency’s processing timelines for various applications. Read More
Aclaris made misleading claims in a TV ad for its seborrheic keratosis treatment Eskata and failed to include details of potential side effects, CDER’s Office of Prescription Drug Promotion said in an untitled letter to the firm. Read More
The FDA has asked Merck to team up with IBM, KPMG and Walmart to put together a new pilot program testing whether blockchain can help regulators track and trace prescription drugs along the increasingly complex supply chain. Read More
The FDA is giving a gentle but clear nudge to industry on stem cells with a new rapid-response program to help regenerative medicine makers to get on the right side of the law. Read More
The FDA’s ad police warned a Campbell, Calif.-based company to stop claiming that its prescription diet pill can help patients lose weight three times faster than diet and exercise alone. Read More