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Gottlieb's FDA

January 29, 2018 | Daily News

FDA will hold a public meeting to discuss how to improve eligibility criteria for clinical trials to better represent the broader patient population and increase diversity, the agency announced Monday (Jan. 29).

January 29, 2018 | Daily News

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.

January 26, 2018 | Daily News

White House regulatory czar Neomi Rao corroborated Friday (Jan. 26) FDA Commissioner Scott Gottlieb's claim that the agency can deregulate by regulating, but she also talked tough on agencies regulating via guidance -- a practice that stakeholders have slammed FDA for in the past.

January 25, 2018 | Daily News

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.

January 25, 2018 | Daily News

In the wake of a controversial policy that ended up getting the agency sued, FDA announced it will release new guidance in March on determining the clinical need to warrant compounding using bulk substances, which one source familiar with the drafting and negotiations around the compounding law says could “right the ship” on bulk compounding.

January 25, 2018 | Daily News

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.

January 25, 2018 | Daily News

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.

January 25, 2018 | Daily News

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.

January 25, 2018 | Daily News

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.

January 24, 2018 | Daily News

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.

January 19, 2018 | Daily News

FDA's drug center released Friday (Jan. 19) its 2018 guidance agenda, which includes new categories focused on over-the-counter (OTC) drug development and rare diseases.

January 18, 2018 | Daily News

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.

January 18, 2018 | Daily News

FDA has clarified through guidance the details of its newest voucher program, which was established through the 21st Century Cures Act and is intended to incentivize sponsors of material threat medical countermeasure (MCM) products -- those that diagnose, prevent or treat illness caused by chemical, biological, radiological and nuclear threats and emerging infectious diseases -- by expediting their review.

January 17, 2018 | Daily News

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.

January 12, 2018 | Daily News

FDA announced on Friday (Jan. 12) that it will continue to delay until further notice a controversial regulatory measure that would factor “the totality of the evidence” into agency decisions regarding a drug or device manufacturer's intended use of a product and communications about such uses.

January 12, 2018 | Daily News

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.

January 12, 2018 | Daily News

FDA and the Centers for Disease Control and Prevention are under fire for an alleged lack of transparency with the public after the agencies declined to warn consumers that romaine lettuce may be the source of an E. coli outbreak.

January 11, 2018 | Daily News

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).

January 11, 2018 | Daily News

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).

January 11, 2018 | Daily News

Prescription opioid cough and cold medicines that contain codeine or hydrocodone are being stripped of their indications to treat cough in kids, FDA announced Thursday (Jan. 11).

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