FDA Policy/General
Federal Register Notices: FDA has posted 10 Office of Management and Budget information collection notices, nine of them health product-focused, that have been backlogged and now released after a regulatory review by the Trump administration. The nine are: * Comment Request: Testing Communications on Medical Devices and Radiation-Emitting Products.
FDA Policy/General
Federal Register Final Order: FDA has classified as a Class 2 (special controls) medical device the continuous glucose monitor secondary display. The special controls that will apply to the device are identified in the order and will be part of the codified language. To view the order, click here.
FDA Policy/General
Federal Register Final Order: FDA has classified as a Class 2 (special controls) medical device the high throughput genomic sequence analyzer for clinical use. The special controls that will apply to the device are identified in the order and will be part of the codified language. To view the order,
FDA Policy/General
Federal Register Final Order: FDA has classified as a Class 2 (special controls) medical device the vibratory counter-stimulation device. The special controls that will apply to the device are identified in the order and will be part of the codified language. To view the order, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 4/5 public workshop on “Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives.” The meeting will provide an overview of the current status of regulatory science initiatives for generic drugs and an opportunity for public input on these areas. FDA will
FDA Policy/General
Federal Register notice: FDA has announced a list of 1,003 Class 2 devices that the agency is proposing to exempt or partially exempt from premarket notification [510(k)] requirements. FDA believes that the devices identified are sufficiently well understood and do not present risks that require premarket notification review
FDA Policy/General
Federal Register notice: FDA has established a public docket to accept comments on its ongoing efforts to enhance mechanisms for patient engagement at the agency, including establishing a new Office of Patient Affairs. The new office would be “tasked with supporting and coordinating patient engagement activities across medical product centers
FDA Policy/General
Federal Register Notice: FDA has announced a 4/5 joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss an Inspirion Delivery Sciences NDA for oxycodone hydrochloride immediate-release oral tablets, indicated for management of moderate
FDA Policy/General
Federal Register Notice: FDA has announced a regional public meeting entitled “U.S. Food and Drug Administration and Health Canada Joint Regional Consultation on International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).” The meeting is intended to provide information and receive comments on the current
FDA Policy/General
[Editorial by Jim Dickinson] For the first time in our 35-year history as the oldest FDA-centered news publisher, Dickinson’s FDA Webview is endorsing a candidate for FDA commissioner: Scott Gottlieb. His nomination, announced by President Trump 3/9, quickly drew predictable alarums about Gottlieb’s “deep ties”
FDA Policy/General
FDA is seeking comments on its ongoing efforts to enhance mechanisms for patient engagement at the agency, including establishing a new Office of Patient Affairs. The agency says this concept was suggested in earlier public feedback received under patient engagement meetings mandated under the FDA Safety and Innovation Act. An
FDA Policy/General
OncBioMune Pharmaceuticals has acquired Vitel Laboratorios, which gives OncBioMune two drugs sold in Mexico — Bekunis for constipation and Cirkused for stress. Vitel has a total of seven other products that are either already in the registration stage or planned for launch later in 2017. Mylan has agreed to the terms
FDA Policy/General
Drug Safety/Anesthetic and Analgesic Meeting Address Change Federal Register Notice: FDA amends a 1/11 notice of a Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee joint meeting. 03/08/2017 Flonase Not Withdrawn Due to Safety/Effectiveness Federal Register Notice:
FDA Policy/General
Former FDA deputy commissioner Scott Gottlieb, who served under George W. Bush, has been nominated by president Donald Trump for the FDA commissioner post. Drug company executives had earlier signaled their preference for Gottlieb, who is a physician and fellow at the American Enterprise Institute. In response to the nomination,
FDA Policy/General
Federal Register Notice: FDA has amended a 1/11 notice of a Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee joint meeting. The meeting address has been changed to: Tommy Douglas Conference Center, 10000 New Hampshire Ave., Silver Spring, MD 20903. To
FDA Policy/General
A study conducted by FDA researchers found that the location of risk information on prescription drug Web sites can affect consumer knowledge of drug risks. However, they found, signals and special formatting may not be necessary to adequately inform consumers about drug risks. In the research, reported in the Journal
FDA Policy/General
HHS secretary Tom Price 3/6 hinted on Hugh Hewett’s talk radio show (view transcript) that an FDA commissioner nomination could be announced as early as this week. Law professor Hewett’s radio show is heard in more than 120 cities across the U.S., with an audience of
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Denttio, Inc. Los Angeles, CA (2/23): FDA inspected the firm 8/2016 and documented GMP deficiencies related to its manufacture of digital x-ray image receptors and intraoral
FDA Policy/General
Federal Register Notice: FDA has determined that GlaxoSmithKline’s allergy drug Flonase (fluticasone propionate) nasal spray, 0.05 mg, was not withdrawn from sale for safety or effectiveness reasons. This determination means the agency will not begin procedures to withdraw ANDA approvals that reference the brand drug product. To view
FDA Policy/General
Federal Register Notice: FDA has announced a 5/4 public meeting and an opportunity for public comment on Patient-Focused Drug Development for autism. The meeting is part of FDA’s performance commitments agreed to under the Prescription Drug User Fee Act (PDUFA V). It is intended to allow FDA
FDA Policy/General
Federal Register Notice: FDA has awarded Biogen a priority review voucher (PRV) for gaining approval of rare disease drug Spinraza (nusinersen), indicated for treating spinal muscular atrophy in pediatric and adult patients. The PRV was awarded under a provision that encourages development of new drugs and biologics for rare pediatric
FDA Policy/General
FDA Global Regulatory Operations and Policy deputy commissioner Howard Sklamberg has left the agency effective 3/3 “to pursue new opportunities.” Sklamberg had reportedly informed former commissioner Robert Califf last September that he planned to leave the agency early this year. Global Regulatory Policy associate commissioner Dara Corrigan will serve