Gottlieb's FDA

An FDA expert panel rejected Philip Morris International’s claim that its smokeless tobacco product, IQOS, could reduce users’ risk of tobacco-related disease, but the experts did approve of the company's claim that the product would reduce a user's exposure to harmful chemicals.

Endo Pharmaceuticals has agreed to a temporary stay of its lawsuit against FDA over the agency's interim policy on compounding using bulk substances until the agency releases new guidance to significantly rework the controversial policy.

Health system pharmacists are largely in the dark on how to comply with FDA's compounding regulations, but the industry hopes that will change in light of FDA's newly announced plan to release guidance on how it will apply compounding regulations to this sector.

Current oversight and regulation of the outsourcing compounding industry is insufficient and enforcement of the current guidelines is too lax, according to a recent white paper that came out of roundtable discussions with top compounding experts.

The National Academies of Sciences, Engineering and Medicine (NASEM) is calling on FDA and its federal research partners to prioritize a number of research initiatives to increase knowledge of e-cigarettes, including the amount of toxicants and nicotine in e-cigarettes, the long-term effects of e-cigarette use, and the potential for e-cigarettes to help with cessation of combustible tobacco cigarettes.

Bipartisan legislation that would launch an over-the-counter (OTC) user fee program coupled with monograph reform cleared the House Energy & Commerce health subcommittee Wednesday (Jan. 17) by voice vote, despite lawmakers grappling with a provision providing two years of exclusivity to innovative OTC drugs.

A bill that would allow drug and device manufacturers to communicate off-label information about their products with payers cleared the House Energy & Commerce health subcommittee on Wednesday (Jan. 17), despite Democratic opposition.

The House Energy & Commerce oversight subcommittee will hold a hearing Friday (Jan. 19) on FDA’s handling of food recalls. The hearing will discuss a recently released report by the HHS Office of Inspector General, which identified key flaws in FDA’s response to food borne outbreaks.

In 2018, FDA will focus on making the process for developing and approving biosimilar drugs more efficient, modernizing its own internal processes and technologies, and developing a comprehensive plan to encourage development of healthy foods, the agency announced in its 2018 Strategic Policy Roadmap released on Thursday (Jan. 11).