FDA Policy/General
Federal Register notice: FDA has determined for patent extension-related purposes the regulatory review period for Kirin-Amgen’s Siliq (brodalumab), indicated for treating moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to
FDA Policy/General
Federal Register notice: FDA has determined for patent extension-related purposes the regulatory review period for Radius Health’s Tymlos (abaloparatide), indicated for treating postmenopausal women with osteoporosis at high risk for fracture. The regulatory review period was determined to be 4,130 days, which includes 3,735 days that
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: Auro Pharmacies La Habra, CA (9/24): FDA inspected the outsourcing facility in June and cited it over serious deficiencies in its
FDA Policy/General
Federal Register notice: FDA has canceled an 11/7 Allergenic Products Advisory Committee meeting that was scheduled to discuss the use of challenge studies in allergenic product clinical development for products intended to diagnose and treat allergies caused by aeroallergens. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a publication containing modifications to the list of standards it recognizes for use in premarket reviews (FDA Recognized Consensus Standards). The publication, “Modifications to the List of Recognized Standards, Recognition List Number: 050” is intended to assist manufacturers who elect to declare conformity
FDA Policy/General
Federal Register notice: FDA has withdrawn the approval of 20 NDAs from multiple applicants after they notified the agency that the drug products were no longer marketed. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined for patent extension-related purposes the regulatory review period for MedImmune’s Imfinzi (durvalumab), indicated for treating patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of
FDA Policy/General
Former FDA Associate Chief Counsel for Enforcement Beth Weinman has joined Ropes & Gray at its Washington, D.C. office as counsel in the firm’s life sciences and FDA regulatory practice. At FDA, she advised Office of Criminal Investigations agents investigating potential criminal violations and worked with the U.
FDA Policy/General
Quantitative Efficacy/Risk Info in DTC Ads Federal Register notice: FDA makes available a draft guidance entitled “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements.” 10/19/2018 Regulatory Review Period for SK Chemicals’ Afstyla Federal Register notice: FDA determines for patent extension-related
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements.” The document describes how to include drug quantitative efficacy or risk information in DTC promotional materials, and to make the language and presentation more consumer-
FDA Policy/General
Federal Register notice: FDA has determined for patent extension-related purposes the regulatory review period for SK Chemicals’ Afstyla (antihemophilic factor (recombinant), single chain), indicated for use in children and adults with hemophilia A (congenital Factor VIII deficiency). The regulatory review period is 1,734 days, including 1,371 days
FDA Policy/General
Federal Register notice: FDA has determined for patent extension-related purposes the regulatory review period for Regeneron Pharmaceuticals’ Dupixent (dupilumab), indicated for treating adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The review
FDA Policy/General
Federal Register notices: FDA has made available the following six medical device classification orders: * Anesthesiology Devices; Classification of the Positive Airway Pressure Delivery System (PDF) * General and Plastic Surgery Devices; Classification of the Wound Autofluorescence Imaging Device (PDF) * General and Plastic Surgery Devices; Classification of the Light Based Energy Source
FDA Policy/General
Federal Register notice: FDA has determined for patent extension-related purposes the regulatory review period for Genentech’s Ocrevus (ocrelizumab), indicated for treating patients with relapsing or primary progressive forms of multiple sclerosis. The regulatory review period is 4,844 days, including 4,509 days that occurred during the testing
Drugs
Experts have varying opinions on the legality and potential effectiveness of a Trump administration proposal to lower drug prices by requiring manufacturers to include pricing information in television ads. That’s the conclusion drawn from a Bloomberg Law online post. Under the proposal announced 10/15, the HHS Centers for
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” The document is intended to help sponsors protect against risks, such as ransomware campaigns, that could disrupt clinical operations and delay patient care. To view the notice, click
FDA Policy/General
Federal Register notice: FDA is seeking comments on a new proposed research study entitled “Experimental Study of an Accelerated Approval Disclosure.” The study will examine the presence, wording, and prominence of a disclosure communicating information related to the drug’s accelerated approval in direct-to-consumer promotional materials. To view
FDA Policy/General
Federal Register notice: FDA is seeking public comments on a proposed research study entitled, “Disease Awareness and Prescription Drug Promotion on Television.” FDA is interested in whether and to what extent disease awareness communications may result in consumers confusing or otherwise misinterpreting the different information and claims presented in these
FDA Policy/General
Federal Register notice: FDA has classified the external upper limb tremor stimulator into Class 2 (special controls). The classification was in response to a Cala Health request for de novo classification of its Cala One. The classification has identified it as a prescription device that is placed externally on the
FDA Policy/General
FDA commissioner Scott Gottlieb says Walmart vice president for food safety and health Frank Yiannis is joining FDA as deputy commissioner for food policy and response, replacing deputy commissioner for foods and veterinary medicine Stephen Ostroff, who is retiring. Among his other duties, Ostroff served twice as acting commissioner for
FDA Policy/General
Current CDRH surveillance and enforcement concerns involving promotional or adverting efforts include unapproved devices (no approval, clearance, or exemption), modified devices (formerly legally marketed but with no approval or clearance for modification), and unapproved/uncleared indications or intended uses. Speaking at a Food and Drug Law Institute conference 10/17
FDA Policy/General
A CDER Office of Prescription Drug Promotion (OPDP) Bad Ad Program complaint says that an Eisai sales representative made false and misleading statements to healthcare professionals about the company’s Fycompa (perampanel) tablets and oral suspension. A 10/11 untitled letter says the sales representative made statements providing evidence that