Devices
FDA says it has formally recognized the genetic variant information in the Clinical Genome Resource consortium’s ClinGen Expert Curated Human Genetic Data database as a source of valid scientific evidence that can be used to support clinical validity in premarket submissions. FDA says this is a significant step forward
Drugs
An online FDA drug science research report says the agency is evaluating an approach to use mass spectrometry to ensure the quality of complex protein therapeutics to treat cancer and other diseases. The document says that recent development of a multi-attribute method (MAM) has allowed mass spectrometry to be
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment.” The document identifies knowledge gaps that represent important challenges in developing such drugs. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA.” The document provides procedures that will promote well-managed post-CRL meetings and help ensure that such meetings are scheduled and conducted in accordance with the commitments
Drugs
The U.S. Justice Department has announced that medical device manufacturer ev3 has agreed to plead guilty to introducing an adulterated medical device into interstate commerce. The Onyx Liquid Embolic System is approved for use as a device that is surgically injected into blood vessels to block blood flow to
Devices
FDA says CDRH is making progress in its strategic priority to develop collaborative communities where stakeholders can work together to achieve common objectives and outcomes, solve shared challenges, and leverage collective opportunities in an environment of trust, respect, empathy, and openness. An online update says CDRH has as a key
Devices
FDA has issued a De Novo Classification Proposed Rule that, when finalized, will establish procedures and criteria for the de novo classification process and become part of the Medical Device Classification Procedures. The document says the new requirements “are intended to ensure the most appropriate classification of devices consistent with
Drugs
FDA has posted a Form FDA-483 citing JCB Laboratories (Wichita, KS) over GMP deficiencies at the drug outsourcing operation. For example, the inspection form said there is no testing to assure that a drug product meets applicable standards of identity, strength, quality, and purity at the time of use.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “FDA Adverse Event Reports; Electronic Submissions — 21 CFR 310.305, 314.80, 314.98, 314.540, 514.80, 600.80, 1271.350, and Part 803” (OMB Control Number 0910-0645). To view the notice, click here.
Drugs
FDA has released a draft guidance entitled “Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment.” The document is intended to assist sponsors by describing the agency’s current thinking about the necessary components of a drug development program for such conditions. It identifies knowledge gaps that represent important
Drugs
FDA has released a guidance entitled “Post-Complete Response Letter (CRL) Meetings Between FDA and ANDA Applicants Under GDUFA.” The document provides recommendations on how such meetings are intended to clarify deficiencies identified in a CRL referencing an ANDA. Post-CRL meetings should be requested in writing by an ANDA
FDA Policy/General
Federal Register notice: FDA has determined for patent extension-related purposes the regulatory review period for Regeneron Pharmaceuticals’ Kevzara (sarilumab), indicated for treating adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs. The regulatory
FDA Policy/General
Federal Register notice: FDA has determined for patent extension-related purposes the regulatory review period for Provepharm’s Provayblue (methylene blue), indicated for treating pediatric and adult patients with acquired methemoglobinemia. The regulatory review period has been determined to be 415 days, which includes 232 days that occurred during the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled: “Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring — 21 CFR Parts 312 and 812” (OMB Control Number 0910-0733). The information collection supports reporting and recordkeeping found in agency guidance. Under 21 CFR parts 312
Devices
AdvaMed has commented on FDA’s recent draft guidance on “The Special 510(k) Program,” suggesting that the document’s “proposed text may cause unintended consequences and unnecessarily restrict changes in certain device types from being reviewed through a Special 510(k), even though there are well-established methods with
Devices
FDA has approved a Medifocus PMA supplement for new labeling for its Prolieve Transurethral ThermoDilatation Therapy based on the results from the company’s benign prostatic hyperplasia (BPH) post-approval study, which showed durable and lasting clinical benefits for at least five years of follow-up. The study involved 225
FDA Policy/General
Draft Guide on Blood Glucose Monitoring 510(k)s Federal Register notice: FDA makes available a draft guidance entitled “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.” 11/30/2018 Draft Guide on OTC Blood Glucose Monitors Federal Register notice: FDA makes available a draft guidance entitled
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.” The document describes studies and criteria that FDA recommends be used when submitting 510(k)s for blood glucose monitoring systems that are for prescription point-of-care
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use.” The document describes studies and information that the agency recommends be used when submitting 510(k)s for self-monitoring blood glucose test systems that are for over-
FDA Policy/General
Federal Register notice: FDA has announced a 1/16 Bone, Reproductive and Urologic Drugs Advisory Committee meeting. Panel members are scheduled to discuss an Amgen BLA for romosozumab injection, indicated for treating osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple
Drugs
FDA has approved a Catalyst Pharmaceuticals NDA for Firdapse (amifampridine) 10 mg tablets for treating adults with Lambert-Eaton Myasthenic Syndrome (LEMS), a rare autoimmune disease that affects about 1 in 100,000 people in the U.S. The most common LEMS symptoms are proximal muscle weakness and fatigue. Symptoms
Drugs
Ten years after launching FDA’s Sentinel medical product safety system, officials are lauding its achievements and future potential. An 11/29 New England Journal of Medicine online perspective notes that Sentinel data are being integrated to inform many CDER regulatory decisions. For example, in the past two years, Sentinel