Drugs
FDA has published a guidance, Consumer Antiseptic Final Rule Questions and Answers, to help small businesses understand and comply with the antiseptic rub final rule that applies to active ingredients used in over-the-counter (OTC) consumer antiseptic rub products, sometimes referred to as rubs, leave-on products, or hand
Drugs
Washington Legal Foundation (WLF) has submitted an amicus brief urging the 7th Circuit Court of Appeals to affirm an Illinois federal court decision in a case involving drug patents under antitrust law. A WLF statement says UCFW Local 1500 Welfare Fund v. AbbVie challenges a settlement between AbbVie and several
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) is calling on FDA to withdraw its 9/24/20 Request for Proposals (RFP) Regarding Insulin Reimportation Programs. A 12/17/20 petition also calls on the agency to: * refrain from reimportation of insulin under section 801(d)(2) of the Federal Food,
Drugs
FDA has published a draft guidance, IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations, to help sponsor-investigators develop such drug products for a severely debilitating or life-threatening genetic disease. The document focuses on the administrative and procedural aspects of interacting with FDA on development
FDA Policy/General
The follow are the Federal Register notices published the week ending 1/01/2021: Federal Register notice: FDA has announced the renewal of the Cellular, Tissue and Gene Therapies Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 10/
FDA Policy/General
The follow are the Federal Register notices published the week ending 12/25/2020: Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Export of Food and Drug Administration-Regulated Products: Export Certificates” (OMB Control Number 0910-0498). To view the notice, click here. Federal Register
FDA Policy/General
FDA has posted the latest Warning Letters posted the weeks ending 12/25/2020 and 1/1/2021. They can be accessed by clicking on the link following each letter. Clientele, Sunrise, FL (12/3/2020): FDA inspected the firm in February 2020 and cited significant GMP violations for finished
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