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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
As part of its ongoing enforcement efforts against drug compounders, the FDA plans to move the program’s base of operations from CDER’s Office of the Center Director to the Office of Compliance, Director Janet Woodcock announced. Read More
The House Appropriations committee approved nearly $3.3 billion in spending for the FDA for fiscal year 2020 and once again nudged the agency to get going on its delayed continuous manufacturing initiative. Read More