Development of the model DFLs was a first for agency, reflecting alarm over public health crisis of overdoses from opioid abuse, which reached nearly 48,000 in 2017. The project was "part of our broader commitment to addressing the opioid crisis" and should help sponsors with potential naloxone OTC switch NDAs, says Commissioner Scott Gottlieb.

Perrigo appeals tax assessment Ireland levied in late December on Rx ingredient royalty rights firm gained when it became incorporated in Dublin but no longer owns, Analysts allowed President and CEO Murray Kessler. benefit of doubt he'll lead Perrigo out of prolonged slump when he joined firm in November after extensive executive experience with tobacco firms and in other consumer goods markets, but they're more circumspect about its chances of prevailing in Irish tax disagreement.

UK Advertising Standards Authority says despite P&G’s modification of a claim in TV ads for Oral B Gum and Enamel Repair toothpaste, visuals in the ad combined with claims suggest the product can repair enamel.

Lawmakers already are taking action to ban sales of oxybenzone- and octinoxate-containing sunscreens due to signals, however questionable, that the ingredients pose dangers to coral health. Now a new study suggests that octocrylene could be a concern as well.

On par with 2017, the Personal Care Products Council was tracking more than 300 state bills last year with potential implications for its members, including measures ultimately enacted by California and Hawaii to deter cosmetic animal testing and ban environmentally questionable sunscreens.

The Florida island city could be the next jurisdiction to prohibit the sale of oxybenzone- and octinoxate-containing sunscreens. Industry maintains that available science does not clearly link the ingredients to coral decline, with the Personal Care Products Council asking to present before the Key West City Commission at its January meeting.