Drugs
Despite challenges from balancing resources to navigate the Covid-19 pandemic, FDA approved 53 new molecular entities in 2020, which is five (10%) more than it approved in 2019 and six shy of 2018’s record 59 approvals. A quick look at the approvals shows that many were for treating
Devices
FDA has just released the FDA-483 with five observations issued following a 1/13-1/16/20 inspection at Legacy Pharmaceutical Packaging, an Earth City, MO, medical device contract manufacturer. The observations were: * failing to adequately validate according to established procedures a process whose results cannot be fully verified
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
Drugs
FDA has released a draft guidance entitled Dry Eye: Developing Drugs for Treatment that is intended to provide recommendations to sponsors about eligibility criteria, trial design considerations, and efficacy endpoints to enhance clinical trial data quality and greater efficiency in development programs for such drugs. It recommends both traditional environmental
Drugs
FDA has approved Myovant Sciences’ Orgovyx (relugolix) for treating adult patients with advanced prostate cancer. “Today's approval marks the first oral drug in this class and it may eliminate some patients’ need to visit the clinic for treatments that require administration by a health care provider,” FDA Oncology
Devices
FDA has approved an Integrum PMA for Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System, intended for adults who have transfemoral (above-the-knee) amputations and who have rehabilitation problems with, or cannot use, a conventional socket prosthesis. The device is surgically anchored and integrated into a patient’
Drugs
FDA is continuing to explore using “remote regulatory assessments” in lieu of conducting physical facility inspections during the Covid-19 public health emergency, according to CDER Office of Compliance director Donald Ashley. Speaking during a virtual Food and Drug Law Institute conference 12/16, Ashley discussed how CDER has adapted
Drugs
Biogen has agreed to pay $22 million to resolve allegations that it violated the False Claims Act by illegally using two foundations, Chronic Disease Fund (CDF) and The Assistance Fund (TAF), as conduits to pay Medicare co-pays for patients taking the company’s multiple sclerosis drugs, Avonex and Tysabri.
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.
Biologics
FDA 12/18 issued an Emergency Use Authorization (EUA) for Moderna’s Covid-19 vaccine for use in individuals 18 years of age and older. The EUA follows a 20 to 0 advisory committee vote the day before recommending its issuance. Shipments of almost six million vaccine doses could begin
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
Drugs
FDA has posted an updated List of Off-Patent, Off-Exclusivity Drugs Without an Approved Generic. The agency says the list includes approved NDAs for drug products that are not protected by patents or exclusivities at the time of the update and for which the agency has not approved an
Drugs
FDA says its review of Web and social media sites maintained by Phoenix Biotechnology and Avila Herbals, San Antonio, TX, indicate that the companies are marketing an Oleander 4X product manufactured by Avila for Phoenix and intended to mitigate, prevent, treat, diagnose, or cure serious and/or life-threatening conditions
Devices
Attorneys Aaron Josephson and Benjamin Zegarelli (Mintz) say in an online post that 2020 was the year that Americans became familiar with lesser-known and niche FDA policies like those governing emergency use authorizations, and with the agency role in regulating laboratory-developed tests. The two use this post to
Drugs
Parenteral Technologies is petitioning FDA to amend the children’s over-the-counter dosage schedule and directions of single-ingredient acetaminophen for ages 2-4 as published in the 11/16/88 tentative final monograph. The 11/21 petition also asks the agency to publish a statement of enforcement policy
Devices
Penumbra has recalled all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) due to a risk of unexpected death or serious injury while used for removing clots in stroke patients. All users should stop using this device, and facilities should remove the
Drugs
FDA is warning consumers not to use nearly 50 male enhancement or weight loss products that have been found to contain hidden ingredients and may pose a significant health risk. An agency statement says FDA purchased the products on Amazon and eBay and then tested them. It reports finding that
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
Drugs
FDA has approved MacroGenic’s Margenza (margetuximab-cmkb), in combination with chemotherapy, to treat adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. A company statement says Margenza is the first HER2-
Drugs
FDA has accepted for priority review a Takeda Pharmaceutical NDA for Eohilia (budesonide oral suspension) for treating eosinophilic esophagitis (EoE), a chronic inflammatory disease that can cause damage to the esophagus. The NDA is based on data from the pivotal Phase 3 trials ORBIT1 and ORBIT2, which investigated the safety