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…in February 2017, FDA deferred action on six active ingredients (benzalkonium chloride, benzethonium chloride, chloroxylenol, alcohol, isopropyl alcohol and povidone-iodine) pending additional data. Thus, the rule making on health care…
As readers of this blog may recall, in March 2020, as part of the CARES Act, the FDC Act was amended to include statutory provisions that (1) reform and modernize…
On April 27, 2018, Petitioners Breckenridge Pharmaceutical, Inc. and Nexgen Pharma, Inc. filed a Petition for Review in the United States Court of Appeals for the District of Columbia Circuit….
…order. FDA must grant meeting within 45 days after date of meeting Adcom: FDA may convene advisory committee (adcom). Final Order: 90 days after closing of comment period, if sufficient…
…dispensed pursuant to a prescription. For example, in Hawaii, a senate bill introduced on January 20, 2011, adds “any material, compound, mixture, or preparation which contains any quantity of [pseudoephedrine]”…
…the sale, resale, or distribution of a covered product, with respect to other buyers of the covered product. (d) COMPETITIVE ACCESS TO REMS PRODUCTSFOR DEVELOPMENT PURPOSES.— (1) PROHIBITED USE OF…
…supplement the diet by increasing the total dietary intake, or (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E).”…
…Part D policy requires that Part D plan sponsors include on their formularies, with limited exceptions, all drugs in six categories or classes: antidepressants, antipsychotics, anticonvulsants, immunosuppressants for treatment of…
…decide the format of the meeting (e.g., videoconference, teleconference, or an in-person meeting). On May 31, 2023, FDA announced that beginning on June 12, 2023, CDER and CBER will expand…
…for prescribing practitioners, 21 U.S.C. § 829(e); and 2) the modified registration requirement for online pharmacies. 21 U.S.C. § 823(f). The Act also established new definitions for “Internet,” “online pharmacy,”…
In April 2007, we reported on a complaint filed by a group of non-profit organizations (including the Association of American Physicians & Surgeons, Concerned Women for America, Family Research Council,…
…safe harbor warning. Proposition 65, California’s Safe Drinking Water and Toxic Enforcement Act of 1986, mandates that businesses that sell consumer products—including food, cosmetics, and OTC drugs—notify Californians about possible…
…the CSA prohibits persons from placing “in any newspaper, magazine, handbill, or other publications, any written advertisement knowing that it has the purpose of seeking or offering illegally to receive,…
…the sale of consumers’ geolocation data to publicly accessible on-line data marketplaces is unfair because it potentially puts those consumers at risk. Advertisers, the complaint says, aren’t the only digital…
…authorities, such as the EPA and the European Commission, which had concluded that glyphosate is not likely to be carcinogenic in humans. In fact, IARC was the only entity that…