FDA CDER’s Office of Nonprescription Drugs recently released its calendar of activities for monograph OTC products on September 30th. Planned activities largely surround GRASE status of active ingredients including codeine, oral benzocaine and/or phenol preparations, and ipecac. Additionally, the office will be reviewing PLLR labeling for NSAIDs; risks and benefits of cough/cold preparations for children under 6yrs; abuse/misuse risks of …
Summary of adverse drug events for hydroxychloroquine, azithromycin, and chloroquine during the COVID-19 pandemic
Dauner DG, Dauner KN. J Am Pharm Assoc (2003). 2021 May-Jun;61(3):293-298.
The United States declared a national emergency concerning the coronavirus disease 2019 (COVID-19) outbreak on March 13, 2020, and on March 28, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the use of oral formulations of hydroxychloroquine (HCQ) and chloroquine (CQ) in …
Industry Update on CBD Containing Dietary Supplements
Rick Kingston, PharmD
President, Regulatory and Scientific Affairs & Sr. Clinical Toxicologist
As most of us know the battle for FDA to allow CBD containing dietary supplements continues to rage. Proponents of FDA action to allow CBD containing dietary supplements have been discouraged by FDA inaction in finding a path forward on that front. Despite such slow movement in that …
SafetyCall’s Dr. Rick Kingston Speaking at Dietary Supplements Regulatory Virtual Summit
SafetyCall International’s Rick Kingston, PharmD, President of Regulatory & Scientific Affairs, will be speaking at the upcoming Dietary Supplements Regulatory Virtual Summit. This is the 5th joint regulatory summit sponsored by trade associations representing companies in this market space, including: AHPA, CHPA, CRN, NPA and UNPA, and in collaboration with the FDA. It is designed to update the industry …
SafetyCall Attends CHFA East
SafetyCall recently attended the Canadian Health Food Association’s (CHFA) eastern regulatory conference on September 12-13th and exhibited at the trade show September 14-15th, 2019. This was the first conference and trade show SafetyCall has attended with CHFA. Plans are already in the works to attend the western show in February 2020.
Much of the talk at the conference mirrored the …
SafetyCall International’s Rick Kingston Takes Critical View of Harvard Study Assessing Risks of Dietary Supplements
Recently, Harvard researchers conducted a study involving dietary supplements, later published in the Journal of Adolescent Health, to review adverse event reports from January 2004 to April 2015 using data from the FDA Adverse Event Reporting System (FAERS). The FAERS is a database that contains line listings of select fields of data from Adverse Event (AE) reports contained …
Listen in as SafetyCall’s Rick Kingston Speaks at FDA Public Hearing
The FDA is seeking public comment regarding the availability of scientific data and information regarding Cannabis or Cannabis derived ingredients. This has been a difficult topic for FDA considering the fact that such products are still classified as Schedule I substances at a Federal level. FDA is looking for scientific information to help them determine if there is a path
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Best Practices in Regulatory Reporting: Are You Compliant with cGMPs?
As Dan Fabricant, Director of the FDA’s Dietary Supplements Program, states in recent communications with Industry, he views the level of non-compliance of dietary supplement manufactures with cGMP’s (current good manufacturing practices) as astonishing. Based on audits that have been completed by the FDA’s compliance division they have estimated that nearly 70% of dietary supplement manufacturers are currently not up …