Drugs
FDA has finalized a guidance on “Competitive Generic Therapies” which describes the process that generic drug applicants should follow to request designation of such a drug and the criteria for that designation. The document provides information on actions the agency may take to expedite ANDA development and review for drugs
Devices
FDA has posted Frequently Asked Questions relating to diagnostic testing for SARS-CoV-2 (popularly known as coronavirus or Covid-19). The document’s first question asks if labs that offer their test under the new FDA policy have to report all their results as presumptive. The agency answers that
Drugs
CDER has issued a Manual of Policies and Procedures (MAPP) on criteria for developing and publishing digital content on the FDA Drugs external Web site. The MAPP also sets standards for ensuring that the Drugs Web site is periodically reviewed for currency, accuracy, and consistency with agency and department policies.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Q3D(R1) Elemental Impurities.” The International Council for Harmonization-prepared document revises the existing guidance “Q3D Elemental Impurities” and provides an updated permitted daily exposure for the cadmium inhalation route of exposure. The updated PDE of 3 micrograms/day
FDA Policy/General
Federal Register notice: FDA has announced a 4/16 public meeting entitled “Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials.” The meeting will be convened by Duke University’s Robert J. Margolis, Center for Health Policy (Duke-Margolis) under a cooperative agreement with FDA. It
FDA Policy/General
Federal Register notice: FDA has reopened the comment period indefinitely on a 4/3/2019 Federal Register notice seeking scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “510(k) Third Party Review Program.” The document provides a comprehensive look into FDA’s current thinking regarding the 510(k) Third Party Review Program. It discusses factors that will be used in determining whether a Class 1 or
Drugs
B. Braun Medical is petitioning FDA to assign AP therapeutic equivalence (TE) ratings to the listings for specified company products in the Orange Book. The petition says the drug products currently have no TE rating assigned. All of the products for which the company seeks an AP rating are considered
Devices
FDA has cleared an Ossio 510(k) for its OssioFiber Hammertoe Fixation System for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis and bone grafts. The bio-integrative implant with disposable, sterile instrumentation comes in three sizes, with both straight and angled configurations for patient customization, the company
Drugs
FDA is alerting healthcare providers and patients to the potential risk of serious or life-threatening infections with the use of fecal microbiota for transplantation (FMT). An agency notice says it is aware of infections caused by enteropathogenic Escherichia coli and Shigatoxin-producing Escherichia coli that have occurred following investigational
FDA Policy/General
FDA said 3/10 it is postponing most foreign inspections through April due to the Covid-19 outbreak. An Alston & Bird FDA Compliance and Enforcement Advisory says that inspections outside the U.S. deemed to be “mission-critical” will be considered on a case-by-case basis. The advisory
Drugs
FDA has granted Boehringer Ingelheim and Eli Lilly a fast track designation for Jardiance (empagliflozin) and its use to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease. An ongoing clinical study (EMPA-KIDNEY) is evaluating the effect of Jardiance on kidney disease
Devices
A day after FDA commissioner Stephen Hahn was criticized during a House Appropriations subcommittee hearing 3/11 about delays in testing and a lack of transparency (see story) amid the coronavirus outbreak, National Institute of Allergy and Infectious Diseases director Anthony Fauci told the House Oversight and Reform Committee that
Drugs
FDA has released the FDA-483 issued following a 1/20-1/24 inspection at Biocon Limited, an active pharmaceutical ingredient manufacturer in Karnataka, India. The five inspection observations on the form were: * failing to adequately perform cleaning validation protocols designed to assess potential product-to-product carryover in non-
Devices
FDA has issued a guidance, 510(k) Third Party Review Program, describing the process FDA uses to recognize qualified third parties to conduct the initial review of 510(k) submissions for certain low-to-moderate risk device eligible for review under the CDRH Third Party 510(k) (3P510k) Review Program.
Drugs
FDA has released the FDA-483 issued following a 2/19-2/28 inspection at Maitland Labs of Central Florida, an Orlando, FL, 503B outsourcing facility. The seven inspection observations were: * aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions; * failing
FDA Policy/General
Federal Register notice: CDER has announced that it will begin supporting the Clinical Data Interchange Standards Consortium for Study Data Tabulation Model version 1.8 (SDTM v1.8), and CDISC Standard for Exchange of Nonclinical Data Implementation Guide — Animal Rule version 1.0 beginning 3/15. This means that these
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Providing Regulatory Submissions in Alternate Electronic Format.” The document addresses submissions (NDAs, BLAs, ANDAs, etc.) that are exempt from the requirement to submit electronically following the agency-recognized electronic common technical document format. It also describes an alternate electronic
Drugs
The Biotechnology Innovation Organization (BIO) says FDA should withdraw its proposed rule to allow the importation of some drugs from Canada “in recognition of the safety and cost hurdles” outlined in the association’s comments on the proposal. The BIO letter says that importation is unlikely to materially affect the
Drugs
For a second time, FDA has rejected an Intarcia Therapeutics implant intended to treat Type 2 diabetes by providing a steady supply of reformulated exenatide to diabetes patients. The agency sent the company a complete response letter, according to the Endpoints online newsletter. The company said it was “extremely disappointed
Devices
In a letter to healthcare providers, FDA provides recommendations for conservation strategies that may be needed as the need for personal protective equipment such as surgical masks, surgical and isolation gowns, and surgical suits may outpace the supply available to healthcare organizations during the Covid-19 outbreak. The letter says
Drugs
FDA has granted accelerated approval to the combination of Bristol-Myers Squibb’s Opdivo (nivolumab) and Yervoy (ipilimumab) for patients with hepatocellular carcinoma who have been previously treated with sorafenib (Bayer’s Nexavar). An FDA announcement says the efficacy of the combination was investigated in cohort 4 of the CHECKMATE-