FDA Policy/General
FDA commissioner Scott Gottlieb flew to Puerto Rico 9/29 to see firsthand the devastation caused by Hurricane Maria. Earlier in the week, the agency deployed additional staff to Puerto Rico to work with pharmaceutical and device companies to prevent shortages of medically necessary drugs and devices, as well as
FDA Policy/General
Federal Register notice: FDA is announcing a 10/6 public workshop entitled “Demonstrating Equivalence of Generic Complex Drug Substances and Formulations: Advances in Characterization and In Vitro Testing.” The meeting is intended to share FDA’s current experiences on evaluating and characterizing critical quality attributes for complex drug substances (e.
FDA Policy/General
Advisory Panel to Review Bayer Drug Federal Register notice: FDA announces an 11/16 Antimicrobial Drugs Advisory Committee meeting that will review a Bayer NDA for ciprofloxacin inhalation powder, indicated for reducing exacerbations in non-cystic fibrosis bronchiectasis adult patients. 09/29/2017 Guide on Advancing Emerging Technology In Drug
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations.” The document is intended to assist sponsors in reproductive toxicity assessments (mainly of embryo-fetal development) for oncology pharmaceuticals and to provide recommendations for product labeling on duration of contraception following
FDA Policy/General
Federal Register notice: FDA is seeking comments or suggestions on issues relevant to the agency’s newly established Opioid Policy Steering Committee. The agency wants feedback on how its authorities can or should be used to address the opioid crisis. It is interested in hearing about three key areas: What
FDA Policy/General
HHS secretary Tom Price has resigned amid a furor over his use of expensive private chartered aircraft for government travel. President Donald Trump plans to designate HHS deputy assistant secretary for health Don J. Wright as acting secretary of the department, which oversees FDA. While Price earlier said his use
FDA Policy/General
Federal Register notice: FDA has announced an 11/16 Antimicrobial Drugs Advisory Committee meeting that will review a Bayer NDA for ciprofloxacin inhalation powder, indicated for reducing exacerbations in non-cystic fibrosis bronchiectasis adult patients with respiratory bacterial pathogens. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a guidance entitled “Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization.” The document provides recommendations to pharmaceutical companies interested in participating in a program involving the submission of emerging manufacturing technology. The agency recognizes that while emerging technology is critical to
FDA Policy/General
Federal Register notice: FDA is requesting that any industry organizations interested in participating in the selection of nonvoting industry representatives to serve on certain panels of the Medical Devices Advisory Committee notify the agency in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on certain committee
FDA Policy/General
Federal Register notice: FDA has announced the renewal of the National Mammography Quality Assurance Advisory Committee. The agency determined that it is in the public interest to renew the committee operations for an additional two years beyond the charter expiration date. The new charter will be in effect until 7/
FDA Policy/General
Federal Register notice: FDA has announced an 11/16 public hearing on a potential approach for device sponsors who seek to obtain marketing authorization for their products that are labeled for a new use with an approved, marketed drug when the drug sponsor does not wish to collaborate on the
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Classification of Products as Drugs and Devices & Additional Product Classification Issues.” The document finalizes two related draft guidance documents issued in 2011. It provides the agency’s current thinking on approaches for classifying products as drugs and devices,
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Shandong Vianor Biotech Co. Linyi Shandong, China (9/12): FDA inspected the firm in May and cited significant GMP violations with finished pharmaceuticals. For example, the firm failed to
FDA Policy/General
Federal Register notice: FDA has published a list of premarket approval applications that have been approved from 7/1/2016 through 6/30/2017. There were no denial actions during this period. The list provides the manufacturer’s name, the product’s generic name or the trade name, and the
FDA Policy/General
Federal Register notice: FDA has announced an educational conference co-sponsored with the Society of Clinical Research Associates on the agency’s clinical trial requirements. The 11/15-16 conference will be held in Lake Buena Vista, FL, and is designed to aid clinical researchers’ understanding of the informed consent
FDA Policy/General
Federal Register notice: FDA is seeking comments on a information collection extension for its “Certification To Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA 3674).” The agency says the information contained in the form is necessary to satisfy a statutory requirement on adherence to the legal requirements
FDA Policy/General
Federal Register notice: FDA has announced an 11/7 Vaccines and Related Biological Products Advisory Committee meeting. Panel members are scheduled to discuss and make recommendations on a clinical development plan for Pfizer’s investigational Staphylococcus aureus vaccine intended for pre-surgical prophylaxis in elective orthopedic surgical populations. To view
FDA Policy/General
Federal Register notices: FDA has made available a draft guidance entitled “Statistical Approaches to Evaluate Analytical Similarity.” The document is intended to provide advice on evaluating analytical similarity to sponsors interested in developing biosimilar products. Specifically, it describes the type of information biosimilars should obtain about the structural/physicochemical and
Drugs
The 5th Circuit Court of Appeals has upheld a Texas federal court grant of summary judgment to Solvay Pharmaceuticals in a False Claims Act (FCA) case brought by two whistleblowers alleging that the company induced false Medicaid claims through off-label marketing and kickbacks to promote Luvox, Aceon, and AndroGel.
FDA Policy/General
Federal Register notice: FDA has announced a 10/24-25 public meeting entitled “2017 Scientific Meeting of the National Antimicrobial Resistance Monitoring System.” The meeting is intended to discuss the current status of the National Antimicrobial Resistance Monitoring System. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 10/27 public workshop entitled “FDA-University of Maryland CERSI Drug Development in Pediatric Heart Failure: Extrapolation, Clinical Trial Design, and Endpoints.” The meeting is intended to address challenges related to the evaluation of products in pediatric heart failure including study population, endpoints,
FDA Policy/General
Federal Register notice: FDA has announced a 10/13 meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee. Panel members will discuss the safety and efficacy of a Aerie Pharmaceuticals NDA for netarsudil ophthalmic solution 0.02%, indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or