Drugs
Six Wilson Sonsini attorneys say FDA enforcement actions were featured in the Justice Department Civil Division’s Consumer Protection Branch’s (CPB) first-ever “recent highlights” report. In an online post, the attorneys say (includes link to report) the report “gives some insight into the enforcement trends companies can expect
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 14 ANDAs from multiple applicants. The applicants notified the agency that the products were no longer marketed and requested that they be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is announcing that all outstanding hearing requests regarding drug products containing an anticholinergic or antispasmodic in combination with a sedative, and single-entity antispasmodic drug products, in oral dosage form, under Docket FDA-1975-N-0336 (formerly 75N–0184) have been withdrawn. Therefore, shipment in interstate
Drugs
Members of Universities Allied for Essential Medicines (UAEM), a global alliance of university students urging their universities to register and report clinical trials, are asking to meet with FDA commissioner Robert Califf to discuss ways in which UAEM and FDA could work together to improve clinical trial transparency. In a
Devices
Medtronic has recalled (Class 1) its Harmony Delivery Catheter due to the potential for a break to occur in the bond holding the capsule at the end of the delivery catheter. The recalled device is part of the company’s Harmony Transcatheter Pulmonary Valve (TPV) System, which is used to
FDA Policy/General
Former FDA principal deputy commissioner Joshua Sharfstein, now a professor at the Johns Hopkins University Bloomberg School of Public Health, says Congress needs to be looking at the impact of the global consulting firm McKinsey working for FDA and Purdue Pharma simultaneously and whether the consultants abused FDA’s trust.
Drugs
Philips Respironics and certain Philips subsidiaries in the U.S. recently received a subpoena from the Department of Justice for information on the events that led to the recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines, according to a first
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Export Notification and Recordkeeping Requirements” (OMB Control Number 0910-0482). The collection pertains to exporters who have notified FDA of their intent to export unapproved products. It identifies the product being exported (e.g., name, description, and
FDA Policy/General
Federal Register notice: FDA is classifying the autofluorescence detection device for general surgery and dermatological use into Class 2 (special controls). The action is based on an AiBiomed de novo classification request for its Parathyroid Detection (Model PTeye) System. The agency has named the classification “autofluorescence detection device for general
Drugs
FDA has issued a four-item Form FDA-483 to Wedgewood Connect after an inspection of its San Jose, CA drug manufacturing facility cited significant GMP violations. For example, the agency says the firm’s responsibilities and procedures applicable to the quality control unit are not in writing and fully
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Public Health Service (PHS) Guideline on Infectious Disease Issues in Xenotransplantation” (OMB Control Number 0910-0456). The guideline was developed by the PHS to identify general principles for preventing and controlling infectious diseases associated with xenotransplantation that
Drugs
CDER’s Office of Prescription Drug Promotion (OPDP) is seeking comments on a research proposal to understand the “Tradeoff Analysis of Prescription Drug Product Claims in Direct-to-Consumer and Healthcare Provider Promotion.” The research is intended to examine the “relative importance of prescription drug product information such as prescription
Drugs
Axsome Therapeutics says it expects to receive a complete response letter on its NDA for AXS-07 (meloxicam-rizatriptan), indicated for the acute treatment of migraine, after the agency recently told the company that chemistry, manufacturing, and controls issues identified during the NDA’s review remain unresolved. The user fee
Devices
The Justice Department says 11 defendants, including the founders of several lab companies — Unified Laboratory Services, Spectrum Diagnostic Laboratory, and Reliable Labs — have pleaded guilty in a $300 million scheme to pay kickbacks to induce medical professionals to order medically unnecessary lab tests, which they then billed to Medicare and
Drugs
FDA has expanded the approval of Gilead Sciences’ Veklury (remdesivir) to include treating Covid-19 pediatric patients 28 days of age and older weighing at least 3 kilograms. FDA says the therapy in this population is for those hospitalized, or not hospitalized but at high risk for progression to severe
Drugs
CDER’s Office of New Drugs say it will convene its Cardiovascular and Renal Drug Advisory Committee to hear an appeal from Ardelyx of a complete response letter (CRL) it received 7/2021 on its NDA for tenapanor to control serum phosphorus in chronic kidney disease patients on dialysis. The
FDA Policy/General
Guide on Nanomaterial in Drugs/Biologics 04/22/2022 Federal Register notice: FDA has made available a final guidance entitled Drug Products, Including Biological Products, That Contain Nanomaterials. The document provides the agency’s current thinking on developing products that contain a nanomaterial in the finished dosage form. To view
FDA Policy/General
Baton Rouge-based OncBioMune Pharmaceuticals is acquiring a generic drug, norepinefrine, that treats low blood pressure and heart failure from Teva Pharmaceuticals Industries. OncBioMune says it is acquiring the intellectual property rights and sanitary certificates — which confirms that the drug has been inspected and meets sanitary requirements — for norepinefrine to
FDA Policy/General
DEVICES FDA has cleared a Fiagon 510(k) for its brain navigation software, BiopsyPointer FlexPointer 1.5 and the ShuntPointer. The device uses an electromagnetic tracking system to locate surgical instruments during a surgery in relation to a patient’s CT scan. It relies on instruments that have a proprietary
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Drug Products, Including Biological Products, That Contain Nanomaterials. The document provides the agency’s current thinking on developing products that contain a nanomaterial in the finished dosage form. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Policy Regarding N-acetyl-L-cysteine. The document explains the agency’s intent to exercise enforcement discretion with respect to the sale and distribution of certain products that contain N-acetyl-L-cysteine and are labeled as dietary supplements.
FDA Policy/General
Federal Register notice: FDA is announcing the availability of an updated guidance entitled Emergency Use Authorization for Vaccines to Prevent Covid–19 (Updated 3/31). The document has been implemented without prior comment, but it remains subject to comment under the agency’s good guidance practices. To view the notice,