FDA Policy/General
Gilead Sciences and its cell-therapy subsidiary Kite Pharma have agreed to acquire Cell Design Labs, a pre-clinical stage biotherapeutics company specializing in custom cell engineering. Under the terms of the agreement, Gilead will acquire all outstanding shares of Cell Design for about $567 million. The transaction will build
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Application for Participation in FDA Fellowship and Traineeship Programs” (OMB Control Number 0910-0780). The collection involves brief online applications completed by applicants applying to FDA’s Fellowship and Traineeship programs. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is proposing to revoke the regulations for human tissue intended for transplantation and human dura mater recovered prior to May 25, 2005. The proposal does not affect the regulations for human cells, tissues, and cellular and tissue-based products recovered on or after May 25, 2005.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Controlled Correspondence Related to Generic Drug Development. The document provides information about the process by which generic drug manufacturers and related industry can submit controlled correspondence to FDA requesting information related to generic drug development and the agency’s
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Dry Eye: Developing Drugs for Treatment. The document is intended to improve clinical trial data quality and to support the development of treatments for dry eye conditions. It provides the agency’s current recommendations regarding eligibility criteria, trial design
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products. The document discusses the use of novel trial designs in the development and regulatory review of drugs and biological products, how sponsors may obtain feedback
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “State Enforcement Notifications — 21 CFR 100.2(d)” (OMB Control Number 0910-0275). The collection supports Section 310(b) of the Federal Food, Drug, and Cosmetic Act that authorizes a state to enforce certain sections of the
FDA Policy/General
Federal Register notice: FDA has announced the issuance of a priority review voucher to Rhythm Pharmaceuticals related to its rare pediatric disease product NDA for Imcivree (setmelanotide) injection, indicated for treating chronic weight management in adult and pediatric patients six years of age and older with proopiomelanocortin, proprotein convertase subtilisin/
FDA Policy/General
Federal Register notice: FDA has announced the issuance of a priority review voucher to Eiger BioPharmaceuticals that is related to its rare pediatric disease product NDA for Zokinvy (lonafarnib), indicated in patients 12 months of age and older to reduce the risk of mortality in Hutchinson-Gilford progeria syndrome. To
Drugs
Sens. Chuck Grassley (R-IA) and Ron Wyden (D-OR) have released a report identifying $65 million in payments made by manufacturers of opioids and opioid-related products to groups focused on pain issues. In a statement (contains a link to the full report), the senators say the opioid manufacturers
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. JC Ayur Life, Yorba Linda, CA (10/29): FDA recently reviewed the company’s Web site and Facebook page and determined that it takes orders for its product “Heritage
FDA Policy/General
Federal Register notice. FDA has made available three device-specific final guidance documents for the Safety and Performance Based Pathway: Spinal Plating Systems — Performance Criteria for Safety and Performance Based Pathway; Orthopedic Non-Spinal Metallic Bone Screws and Washers — Performance Criteria for Safety and Performance Based Pathway; and Magnetic Resonance
FDA Policy/General
FDA has approved Revivicor’s intentional genomic alteration (IGA) in GalSafe pigs for use as food and human therapeutics. “This is the first IGA in an animal that the FDA has approved for both human food consumption and as a source for potential therapeutic uses,” an FDA release says The
FDA Policy/General
Notice Corrected on Drug Development Tools Guide Federal Register notice: FDA is correcting an 11/25 notice entitled Qualification Process for Drug Development Tools; Guidance for Industry. The document was published with incorrect information in the Paperwork Reduction Act of 1995 section, and this notice corrects the error. To view
FDA Policy/General
Federal Register notice: FDA is correcting an 11/25 notice entitled Qualification Process for Drug Development Tools; Guidance for Industry. The document was published with incorrect information in the Paperwork Reduction Act of 1995 section, and this notice corrects the error. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 10 ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed. The applicants also waived their opportunity for a hearing. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has extended the comment period on a draft guidance entitled Electromagnetic Compatibility of Medical Devices. Electronic or written comments can be submitted until 2/16/2021. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced the renewal of its Bone, Reproductive and Urologic Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 3/23/2022. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is withdrawing the approval of an Allergan Pharmaceuticals International NDA for Asacol (mesalamine) delayed-release tablets, 400 mg. The withdrawal decision is based on FDA concerns about certain phthalate esters, including dibutyl phthalate (DBP), being developmental and reproductive toxicants in laboratory animals. Asacol (mesalamine) contains DBP
FDA Policy/General
Federal Register notice: FDA has announced the names of the members who will serve on its fiscal year 2020 Performance Review Board. The board is intended to provide fair and impartial review of staff’s Senior Executive Service, Senior Professional, 21st Century Cures Act, and Title 42(f) performance appraisals,
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a healthcare professional e-mail for Azurity Pharmaceuticals’ Xatmep makes false or misleading claims and/or representations about the drug’s risks and efficacy. An 11/24 Notice of Violation says the violations are especially concerning from a public health perspective
FDA Policy/General
HHS published 12/7 a rulemaking formally adopting good guidance practices (GGP) that are to be followed by all component HHS agencies, including FDA. Attorney T. Daniel Logan (Kleinfeld Kaplan Becker) outlines the impact on FDA, which has had its own different good guidance practices that were adopted 20 years