Drugs
CDER director Janet Woodcock and two agency colleagues say FDA is focused on identifying additional areas in which real-world data may be used to generate evidence of effectiveness. Writing in the Journal of the American Medical Association, the three say the effort will require both an assessment of the
Drugs
Attorney James Czaban (Piper) says that although it has no direct authority to take action on drug pricing, “FDA has been an incredibly active player in the current administration’s efforts to address concerns about drug prices.” Writing in a Food and Drug Law Institute online post, Czaban outlines agency
Drugs
Federal Register notice: FDA has announced a 10/3 Vaccines and Related Biological Products Advisory Committee meeting. Panel members are scheduled to discuss and make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2019 southern hemisphere influenza season. To view the notice,
Drugs
FDA commissioner Scott Gottlieb says the agency and the National Institutes of Health will co-host a 9/17 workshop to discuss microbiome-based products and how manipulation of the microbiome may potentially be used to prevent or treat a variety of different diseases. “Presentations will be given on a
Drugs
CDER says FY 2019 User Fee Program Fee invoices were emailed 8/15 with a 10/1 due date for the $309,915 fee. The Center says that if firms do not receive an invoice by 8/17, PDUFA User Fee staff should be contacted at 301-796-7900 or
Drugs
FDA has accepted for review an Evoke Pharma 505(b)(2) NDA for Gimoti, a nasal spray product candidate for relieving symptoms in adult women with acute and recurrent diabetic gastroparesis. The agency has set a user fee target review date of 4/1/2019. “We believe that Gimoti holds
Drugs
FDA has approved Sun Pharmaceutical Industries’ Cequa (cyclosporine ophthalmic solution) 0.09%, indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye). The drops provide the highest FDA-approved concentration of cyclosporine A and is the first cyclosporine A product that incorporates a nanomicellar technology, according to the
Drugs
Endo International says it has lifted its temporary stay of litigation against FDA seeking a declaration that the agency’s interim policy on compounding using bulk drug substances under Section 503B of the Drug Quality and Security Act of 2013 is contrary to law because it authorizes bulk compounding of
Drugs
FDA has approved Eisai and Merck’s kinase inhibitor Lenvima (lenvatinib) for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). Approval was based on results from REFLECT (Study 304), where Lenvima demonstrated a proven treatment effect on overall survival, as well as statistically significant superiority and clinically
Drugs
Pharmaceutical Research and Manufacturers of America says it generally supports the FDA proposed limited population pathway for antibacterial and antifungal drugs (LPAD) and provides comments on the draft guidance: need for revisions to accurately reflect statutory language; FDA LPAD pathway eligibility determinations made at a time of approval may discourage
Drugs
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application” (OMB Control Number 0910–0636). Comments sought are related to estimates of annual submissions. The guidance discusses what should
Drugs
Pew Charitable Trusts says that an FDA proposed limited population antibacterial drug pathway gives the agency a mechanism to review and approve new antibiotics specifically for use in patients with unmet medical needs. In a comment to an agency docket on the pathway, Pew says the pathway allows approval of
FDA Policy/General
FDA says it is overcoming the lack of acute and chronic pain management information specifically tailored to veterinary medicine with issuance of a new resource with information and recommendations for veterinarians who stock and administer opioids. The intent, according to a statement from FDA commissioner Scott Gottlieb, is to ensure
Drugs
FDA has approved Vertex Pharmaceuticals’ Kalydeco (ivacaftor) to include use in children with cystic fibrosis (CF) ages 12 to 24 months who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to therapy based on clinical or in vitro assay data. Approval
Drugs
Westminster Pharmaceuticals has recalled all lots, within expiry, of its thyroid drugs levothyroxine and liothyronine 15 mg, 30 mg, 60 mg, 90 mg, and 120 mg because they were manufactured using active pharmaceutical ingredients that were sourced prior to an FDA Import Alert against Sichuan Friendly Pharmaceutical Co., according to
Drugs
Office of New Drugs (OND) chief of staff Patrick Frey is leaving the agency 8/24 to join Amgen as Global Regulatory Policy and R&D director. Frey joined the agency in 2008 as an operations research analyst in CDER’s former Office of Planning and Analysis. In 2015,
Drugs
FDA and NIH are proposing to relax some oversight of gene therapy trials to help expedite product development. Writing in a New England Journal of Medicine online perspective, FDA commissioner Scott Gottlieb and NIH director Francis Collins announce their reevaluation of the U.S. oversight system for such trials. “As
Drugs
Federal Register notice: FDA has reopened the comment period on a draft guidance entitled Elemental Impurities in Animal Drug Products — Questions and Answers.” To view the notice, click here.
Drugs
FDA intends to discuss modernizing its NDA assessments through a “Knowledge-Aided Assessment and Structured Application (KASA)” initiative. At a 9/20 joint Pharmaceutical Science and Clinical Pharmacology Advisory Committee meeting, the agency will seek input on the “potential enhancement of a submission format consistent with KASA to improve the
Drugs
An 11/6-11/17/17 FDA inspection at the Apotex Research Private Limited drug manufacturing facility in Bangalore, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to an 8/9 Warning Letter. The specific violations cited in the letter were: * failing to
Drugs
A 11/28-12/7/17 FDA inspection at Paramesh Banerji Life Sciences, North Brunswick, NJ, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. An 8/7 Warning Letter says the violations were: * failing to establish adequate written procedures for production and process control designed
Drugs
FDA Oncology Center of Excellence director Richard Pazdur says a draft guidance, Use of Expansion Cohorts in First-in-Human Clinical Trials to Expedite Development of Cancer Drugs and Biologics, published 8/2018, is intended to “help advance effective and innovative clinical trial designs early in drug development to help