Drugs
A 4/25-5/9/22 FDA inspection at MD Pharmaceutical Supply, in Hanover, PA, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients. A just-released 11/22/22 Warning Letter says specific deviations were: * failing to adequately investigate and document complaints or any
Devices
A 6/17/22-7/5/22 attempted FDA inspection at RoyalVibe Health, The Woodlands, TX, determined that the firm manufactures, markets, and distributes several medical devices and associated software and apps. A just-released 11/18/22 Warning Letter says the company does not have an approved PMA or
Drugs
A 9/21/21-11/4/21 FDA inspection at the Plattsburgh, NY, drug outsourcing facility acquired by Sagent Pharmaceuticals identified serious deficiencies in the firm’s practices for producing drug products intended to be sterile. A just-released 7/27/22 Warning Letter says violations of the Federal Food,
Devices
FDA says it has updated the CDRH Recognized Consensus Standards database. An agency notice says the so-called List 59 update includes new standards and new versions of recognized standards plus revisions to some standards’ extent of recognition and an extension of the transition period for two standards. FDA says
Drugs
FDA has modified the mifepristone REMS program to allow Mifeprex (commonly referred to as an abortion drug) and its approved generic to be dispensed by certified pharmacies or by or under the supervision of a certified prescriber. An agency question-and-answer notice says the change was made in response
FDA Policy/General
The recent signing of the year-end omnibus legislation (HR 2617, Consolidated Appropriations Act, 2023) not only provided FDA with a $226 million bump in its spending level (see story), but it also included notable agency reforms that were part of the user fee reauthorization legislation last summer but eventually
Drugs
FDA says Accord Healthcare recalled daptomycin for injection 500 mg/vial and daptomycin for injection 350 mg/vial in one lot due to a labeling mix-up. An agency notice says the recall came after the company received a complaint from a hospital pharmacy that labels were found misapplied to
Drugs
FDA has approved Acer Therapeutics’ NDA for Olpruva (sodium phenylbutyrate) to treat patients with urea cycle disorders. The approval letter says Olpruva for oral suspension is approved as adjunctive therapy to standard of care, including dietary management, for the chronic management of some adult and pediatric patients with urea cycle
Drugs
FDA has lifted its partial clinical hold for patients under age 18 in studies evaluating Bluebird Bio’s lovotibeglogene autotemcel (lovo-cel) for sickle cell disease. A company statement says the agency placed the studies on a partial hold for patients under age 18 in 12/2021 relating to a
Drugs
CDER Office of Prescription Drug Promotion researchers have taken a first look at the tradeoffs for consumer understanding of a drug’s risks and benefits when drugs are promoted in online character space limited (CSL) communications such as Twitter and Google sponsored links. A report says that some stakeholders have
Drugs
A 10/18/21-10/29/21 FDA Bioresearch Monitoring Program inspection at a clinical site maintained by Dr. Adarsh Daswani in La Palma, CA, found “objectionable conditions” in his conduct of a clinical investigation of an investigational drug. A 12/14/22 Warning Letter says it appears that Daswani
Devices
Attorneys Jeffrey Gibbs and Sara Koblitz (Hyman, Phelps & McNamara) say FDA lobbied to have language included in the appropriations bill for FY 2023 to reverse, at least in part, some of the agency’s recent court losses. Language the agency was seeking is part of the omnibus spending bill
Drugs
An 11/17/21-12/15/21 FDA inspection at the DuPont Nutrition USA excipient manufacturing plant in Newark, DE, found significant deviations from current good manufacturing practice (CGMP) regulations for the manufacture of its excipient Avicel, which FDA says is extensively used as a major component in a wide
Devices
FDA says two issues appeared at the end of 2022 in certain reworked Philips Respironics Trilogy 100 and 200 ventilators. An agency statement says those ventilators were recalled in 6/2021 for issues with the polyester-based polyurethane (PE-PUR) sound abatement foam breakdown. It says the latest issues are:
FDA Policy/General
FDA assistant commissioner for criminal investigations Catherine Hermsen, who retired at the end of 2022 after five years as the agency’s “top cop,” says she expects a greater focus in the future on multilateral collaboration to keep up with the ever-evolving transnational criminal groups. “FDA has been strengthening
Drugs
Except for a defensive FDA statement (below), other reactions to a 12/30 report by two House committees on FDA’s 2021 controversial review and approval of Biogen’s Alzheimer’s drug Aduhelm are sharply critical of the approval and the agency’s decision to work so closely with the
Drugs
A 7/18-7/22/22 FDA inspection at the Nortec Quimica drug manufacturing facility in Rio de Janeiro, Brazil, identified significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). A 12/8/22 Warning Letter said the specific deviations were: * failing to exercise sufficient
Drugs
FDA has revised its information sheet for the Plan B One-Step (1.5 mg levonorgestrel) emergency contraceptive to clarify that the product does not cause an abortion. The revision says that “Plan B One-Step will not work if a person is already pregnant, meaning it will not affect
Drugs
An Oklahoma federal court has entered a consent decree against Qualgen, a drug outsourcing facility that FDA says has a “history of violations.” An agency statement says the decree prohibits the company from directly or indirectly distributing adulterated drugs in interstate commerce. The consent decree was entered against Qualgen, its
Drugs
FDA has published the International Council for Harmonization (ICH) M11 Guideline, M11 Electronic Structured Harmonized Protocol, describing the processes and procedures directing the conduct and analysis of a clinical trial of medicinal products in humans. The document says that to date no internationally adopted harmonized standard has been established for
Drugs
Attorney Heidi Gertner (Hogan Lovells) says an FDA Federal Register notice aiming to help facilitate the development of nonprescription naloxone drug products, including the switch of certain naloxone drug products from prescription to nonprescription status, “demonstrates the agency’s trend toward promoting prescription to over-the-counter switches.” Writing in
Drugs
FDA has published a guidance, Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims, to assist applicants in developing labeling for cardiovascular outcome claims for drugs that are indicated to treat hypertension. The document says that with few exceptions, current labeling for antihypertensive drugs does not include information on the clinical