FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Center for Reproductive Health/ Joliet IVF LLC Crest Hill, IL (7/6): FDA inspected the firm in February and cited deviations from the regulations governing human cells, tissues, and
Drugs
FDA has accepted an Otonomy supplemental NDA seeking approval of Otiprior (ciprofloxacin otic suspension) as a treatment for acute otitis externa (swimmer’s ear). The agency has set a user fee review action target date of 3/2/2018. Otiprio is a fluoroquinolone antibacterial currently indicated for treating pediatric patients
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Adverse Experience Reporting for Licensed Biological Products; and General Records — 21 CFR Part 600.” The regulation requires licensed manufacturers to report each adverse experience that is both serious and unexpected, whether foreign or domestic, as soon as
FDA Policy/General
Federal Register notice: FDA is seeking comments on a new information collection related to a “Draft Guidance for Industry — How To Prepare a Pre-Request for Designation” for feedback from the Office of Combination Products (OCP) on whether a medical product will be regulated as a drug, a device, a
Drugs
Attorney Michael Blume (Venable) says that even though the Supreme Court declined to hear the appeal of Quality Egg owners Jack and Peter DeCoster from their three-month sentence after pleading guilty to misdemeanor violations of the Federal Food, Drug, and Cosmetic Act (FFDCA), the Justice Department briefs submitted in
FDA Policy/General
With hundreds of key vacancies to fill at FDA, commissioner Scott Gottlieb has ordered a “comprehensive” review of the agency’s hiring practices and procedures. “We know that our traditional approach to recruiting and hiring is not as efficient as it should be to attract, hire, and retain the types
Drugs
FDA has issued Amgen a Complete Response Letter on its BLA for the Evenity (romosozumab) as a treatment for postmenopausal women with osteoporosis. The initial submission included data from the pivotal Phase 3 placebo-controlled FRAME study of postmenopausal women with osteoporosis. “With the availability of data from the Phase
Drugs
FDA has approved a Puma Biotechnology NDA for Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. FDA says Nerlynx is the first therapy approved to be taken after an initial treatment to further lower the risk of the cancer coming back. It is indicated
Drugs
FDA has accepted for priority review a Spark Therapeutics BLA for Luxturna (voretigene neparvovec), a investigational gene therapy for treating patients with vision loss due to confirmed biallelic RPE65-mediated inherited retinal disease. The agency has set a 1/12/2018 user fee review target date. The submission is based
Drugs
FDA has proposed new research to be conducted on prescription drug promotional messages that are embedded in character space-limited online prescription drug communications. An agency notice says that certain online communication efforts (e.g., Twitter, sponsored link promotion and microblog messaging) has led to questions about how to use
Drugs
FDA has posted a “REMS Platform Standards Initiative: Needs Assessment” document that is intended to help standardize risk evaluation and mitigation strategies (REMS) with elements to assure safe use, and better integrate them into the growing electronic healthcare system. The initiative is intended to support data standards development to facilitate
Drugs
FDA has told Repros Therapeutics that its clinical development program for Proellex, an oral delivery mechanism for telapristone acetate for treating uterine fibroids, will remain on partial clinical hold based upon its review of existing liver function safety data. The agency has also indicated that the company will be required
Drugs
FDA has revised an internal policy on “Communicating Drug Approval Information” that demands quicker online posting, from three days to two days, for the approved labeling for recently approved drugs. The policy also lays out the posting schedule for approved risk evaluation and mitigation strategy documents, a summary review and
Devices
FDA has cleared a CSA Medical 510(k) to expand the use of its truFreeze catheter offerings to include a third spray kit called RapidAV Spray Kit. “The RapidAV catheter has a material property change such that it provides the ability to shorten the time to liquid nitrogen spray by
FDA Policy/General
Draft Guidances for ANDA Bioequivalence Study Designs Federal Register notice: FDA announces the availability of additional draft and revised draft product-specific guidances that provide product-specific recommendations on bioequivalence study designs. 07/14/2017 2 Animal Drugs Withdrawn on Sponsor’s Request Federal Register notice: FDA withdraws approval of
Drugs
Responding to a National Academies of Sciences, Engineering, and Medicine report on the nation’s opioid epidemic, FDA commissioner Scott Gottlieb highlighted steps the agency is taking as part of his commitment to reduce the scope of the epidemic. In a statement, Gottlieb says that reducing the epidemic is his
FDA Policy/General
Federal Register notice: FDA has announced the availability of additional draft and revised draft product-specific guidances that provide product-specific recommendations on bioequivalence study designs for potential ANDAs. To view the guidances, click here. To view the notice, click here.
Drugs
Mallinckrodt has filed a citizen petition asking FDA to assure that follow-on drug products citing its Inomax (nitric oxide) 800 ppm for inhalation as the reference listed drug include features necessary for the safe and effective administration of inhaled nitric oxide. Two previous petitions seeking similar actions were earlier
Drugs
FDA’s Oncologic Drugs Advisory Committee has voted 17-0 to support approval of an Amgen BLA for a biosimilar version of Roche’s Avastin (bevacizumab) and its use in six non-exclusivity-protected indications. In a separate 16-0 vote, the panel backed approval for a Mylan BLA for
Drugs
FDA has approved a Janssen Biotech BLA for Tremfya (guselkumab) for treating adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Tremfya works by selectively blocking IL-23, a cytokine that plays a key role in plaque psoriasis. Approval follows an expedited regulatory review
Drugs
FDA has approved an Amgen supplemental BLA for Blincyto (blinatumomab) to include overall survival data from the Phase 3 TOWER study. The approval converts Blincyto’s accelerated approval to a full approval. The sBLA approval also included data from the Phase 2 ALCANTARA study supporting the treatment of patients with
Drugs
FDA has granted Sangamo Therapeutics a fast track designation for SB-318 and SB-913, two clinical stage in vivo genome editing product candidates for treating Mucopolysaccharidosis Type I (MPS I) and MPS II, respectively. MPS I and MPS II are caused by mutations in the genes encoding alpha-L-