FDA Policy/General
Federal Register notice: FDA is withdrawing the approval of two Eisai NDAs for Belviq (lorcaserin HCl) tablets and Belviq XR (lorcaserin HCl) extended-release tablets, indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in certain adults. In 2019, FDA issued a
Drugs
FDA has accepted for review a ChemoCentryx NDA for avacopan, an orally-administered selective complement 5a receptor inhibitor for treating antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. The agency has set a 7/7 user fee review action target date. The company says ANCA-associated vasculitis is a systemic disease in
Drugs
The Justice Department says a 16-count indictment charges that two Florida men conspired to pay and receive kickbacks in connection with prescribing an Insys fentanyl spray. Those charged were pain management doctor Steven Chun and former Insys sales representative Daniel Tondre. A department statement says that Insys sales representatives
Drugs
FDA Office of Dietary Supplement Programs director Steven Tave told the 2020 Dietary Supplement Regulatory Summit 9/16 that while it is not correct to say that the dietary supplements industry is not regulated, “we can comfortably say at a minimum that the dietary supplement market isn’t perfectly regulated.
Drugs
FDA has accepted for priority review a CytRx NDA for arimoclomol for treating Niemann-Pick disease Type C. CytRx says that arimoclomol works by amplifying the production of heat-shock proteins, which can rescue defective misfolded proteins, clear protein aggregates, and improve the function of lysosomes. The agency has set
Drugs
President Trump and his administration’s “meddling for political purposes” in FDA and CDC activities related to Covid-19 puts the nation at risk, warns a Washington Post editorial board opinion piece. The Post looks at Trump’s touting of hydroxychloroquine and the expanded use of convalescent plasma as examples
Drugs
FDA says that stakeholders concerned about protecting proprietary information during the development of drugs containing cannabis and cannabis-derived compounds should consider using the drug master file (DMF) pathway. The agency explained the potential use of the DMF pathway for cannabis drug development during a recent Webinar that covered DMFs
FDA Policy/General
Federal Register notice: FDA has issued a priority review voucher to AstraZeneca for an approved rare pediatric disease product — Koselugo (selumetinib), indicated for treating pediatric patients two years of age and older with neurofibromatosis Type 1 who have symptomatic, inoperable plexiform neurofibromas. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Geriatric Information in Human Prescription Drug and Biological Product Labeling. The document provides recommendations to help ensure that appropriate geriatric information is consistently placed in the proper sections and subsections within labeling. It also provides examples of geriatric use
Drugs
The California legislature has passed SB 852 that would require the state to partner with industry “to produce or distribute generic prescription drugs and at least one form of insulin, provided that a viable pathway for manufacturing a more affordable form of insulin exists at a price that results in
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Eosinophilic Esophagitis: Developing Drugs for Treatment. The document addresses the agency’s current thinking about clinical trials and development programs for such drugs, including recommendations for the necessary attributes of patients for enrollment, trial design, efficacy considerations, safety assessments,
Drugs
The DC federal court says FDA misinterpreted the Federal Food, Drug, and Cosmetic Act (FFDCA) when it approved Lannett’s Numbrino (cocaine HCl) nasal solution during the period of Genus Lifesciences’ five-year new chemical entity exclusivity for Goprelto (cocaine HCl) nasal solution. Genus filed suit after the agency approved
Devices
After failing to convince FDA commissioner Stephen Hahn that the agency should give up its responsibility for evaluating the safety and accuracy of laboratory-developed Covid-19 tests, HHS secretary Alex Azar took the matter into his own hands and revoked FDA’s ability to evaluate the tests. In an
Drugs
FDA has announced a 10/30 virtual public workshop on “New Drugs Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation.” The event is intended to solicit public feedback on characteristics of the integrated review document and how the integrated assessment can continue to
Devices
An update on the status of the FDA software precertification program indicates the evaluation of the pilot program will continue, apparently with no additional pilot participants and no indication that the program will be operational any time soon. Attorneys Allison Fulton and Julia Kadish (SheppardMullin) write in their firm’s
Devices
FDA has classified as Class 1 a recall involving a Becton Dickinson CareFusion recall of its Alaris Syringe and Alaris PCA Modules due to potential incorrect display of syringe types and sizes. A recall notice says the display errors could result in delays in infusion, under-infusion, or over-infusion,
Biologics
CBER has updated its calendar year 2020 guidance agenda listing 29 guidances the Center plans to publish this year. The agenda lists 14 planned guidances under Blood and Blood Components, 10 under Tissues and Advanced Therapies, two under Vaccines, and three under Other.
Devices
FDA has approved GE Healthcare’s shatterproof polymer +PLUSPAK Pharmacy Bulk Package for use with its macrocyclic gadolinium-based MRI contrast agent, Clariscan (gadoterate meglumine). The bulk package is designed to reduce the risk of breakage and injury from broken glass, the company says, adding that injuries associated with glass
Drugs
The Alliance for Regenerative Medicine says CBER was under-represented in an independent third-party review assessment of FDA-sponsor communication practices during the IND stage of new drug/biologic development. The group says that “in light of the resource constraints and staggering number of active INDs with CBER,” FDA
FDA Policy/General
An Axios/Ipsos poll conducted on 9/11-9/14 finds that fewer than 10% of Americans have a great deal of trust in FDA or in drug companies to look out for their interests. The firms say the poll results show how difficult it may be to get Americans
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Kalchem International, Lindsay, OK (8/27): FDA inspected the firm in February and found significant GMP violations for finished pharmaceuticals and active pharmaceutical ingredients (APIs). For example, Kalchem failed
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a radio ad for Sprout Pharmaceuticals’ Addyi (flibanserin) tablets makes false or misleading claims about the drug’s risks and omits other material facts. An 8/31 Warning Letter says the violations “are concerning from a public health perspective because they