FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension on “Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun)).” FDA regulation authorizes it to require manufacturers to report medical device-related deaths, serious injuries, and malfunctions. It also requires user facilities to report device-related
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection “Application for FDA Approval To Market a New Drug.” This notice solicits comments on the requirements governing marketing applications for new drugs. To view the notice, click here.
FDA Policy/General
House FDA budget lawmakers 5/25 dismissed the Trump Administration’s request (see earlier story) to renegotiate user fee agreements to increase the fees by $1.2 billion to offset budget authority decreases. Fresh on the job after two weeks, FDA commissioner Scott Gottlieb represented the agency at a House
FDA Policy/General
Federal Register notice: FDA is publishing a list of information collections that have been approved by the Office of Management and Budget. Collections approved include Biological Products: Reporting of Biological Product Deviations and Human Cells; Tissues, and Cellular and Tissue-Based Product Deviations; Form FDA 3486 and Addendum, 3486A; Designation
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a direct-to-consumer TV ad for Orexigen’s Contrave (naltrexone HCl and bupropion HCl) extended-release tablets makes false or misleading representations about the risks associated with the drug. “This violation is concerning from a public health perspective because it
FDA Policy/General
Manhattan Research says that just 27% of doctors surveyed find drug company Web sites to be credible sources of professional information. Doctors value useful drug company content that helps them do their jobs better such as quality scientific information, patient education, and diagnostic tools, the firm’s Taking the Pulse
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection for “FDA Advisory Committee Membership Nominations — OMB Control Number 0910.” Comments are requested on the FDA Advisory Committee Membership Application for accepting nominations of technically qualified experts. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension on “Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile — OMB Control Number 0910–0614.” The notice solicits input on the information collection requirements related to the exceptions or alternatives to labeling requirements
FDA Policy/General
FDA 5/23 alerted veterinarians and dog owners to a risk of accidental overdose in administering Sileo (dexmedetomidin), an oral prescription gel marketed by Parsippany, NJ-based Zoetis for canine noise aversion. According to an FDA news release, Sileo is packaged in a dosing syringe with a ring-stop mechanism
FDA Policy/General
The Trump Administration’s just-released budget request is proposing to increase user fee collections in fiscal year (FY) 2018 by $1.306 billion (68%) over current FY 2017 levels to $3.223 billion. For example, prescription drug fees would jump by $508 million in 2018 — increasing by 67% from
FDA Policy/General
Federal Register notice: FDA seeks comments on an information collection extension for its “Guidance for Industry — User Fee Waivers, Reductions, and Refunds for Drug and Biological Products—OMB Control Number 0910–0693.” The notice solicits comments on recommendations to applicants considering whether to request a waiver or reduction in user
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension related to “Providing Waiver-Related Materials in Accordance With the Guidance for Industry on Providing Post-Market Periodic Safety Reports in the International Conference on Harmonization E2C (R2) Format.” The guidance is intended to promote a consistent approach
FDA Policy/General
Federal Register notice: FDA has announced a 6/20 Endocrinologic and Metabolic Drugs Advisory Committee meeting. The panel is scheduled to discuss a supplemental NDA for Novo Nordisk’s Victoza (liraglutide) injection for a proposed additional indication as an adjunct to standard treatment of cardiovascular risk factors to reduce the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension on “Prescription Drug Advertisements; OMB Control Number 0910–0686.” The agency’s information collection requires that manufacturers who advertise prescription human and animal drugs, including biological products for humans, disclose in advertisements certain information about the advertised product’
FDA Policy/General
AstraZeneca has sold the European commercial rights to its beta-blocker heart drug Seloken and the associated fixed-dose combination Logimax to Italy-based Recordati for $300 million. Seloken (metroprolol) is used to control conditions such as hypertension, angina pectoris, disturbances of cardiac rhythm, maintenance treatment after myocardial infarction and
FDA Policy/General
FDA Amends Animal Drug Regs to Reflect Approvals 05/17/2017 Federal Register final rule: FDA amends the animal drug regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during January and February. FDA Withdrawing Approval of Sioux Bio Animal Drug 05/
FDA Policy/General
Newly sworn-in FDA commissioner Scott Gottlieb will visit Capitol Hill for his first testimony as the agency head 5/25 during a House budget hearing. FDA observers will closely watch for Gottlieb’s stance on the Trump Administration’s proposed budget for FDA in 2018, which cuts the agency’
FDA Policy/General
In his first address to FDA staff, commissioner Scott Gottlieb 5/15 talked about scientific advances that will give employees “better tools to do our regulatory work. Many of these tools and resources are being developed right here at FDA, in our labs, and at places like NCTR. Twenty-first
FDA Policy/General
Federal Register notice: FDA has extended until 7/18 the comment period on a final rule that clarifies for drug and device manufacturers the agency’s interpretation and application of its existing definitions of “intended use” (see earlier story). The comment extension is related to a citizen petition from medical
FDA Policy/General
The House Energy and Commerce Subcommittee on Health 5/18 marked-up and advanced the FDA Reauthorization Act (FDARA) of 2017, that would reauthorize user fee programs for five years beginning 10/1. Four amendments were passed by voice, and they were offered by: Reps. Joseph P. Kenedy, III (D-
FDA Policy/General
University of North Carolina researchers looking at awareness of and trust of FDA and the Centers for Disease Control (CDC) have identified some demographic variables that suggest audiences the agencies may want to target with communications aimed at improving the level of trust. Writing in the open-source journal PLOS
FDA Policy/General
Former FDA commissioner Robert Califf has accepted the position of vice chancellor for health data science for Duke Health. In this capacity, Califf also becomes the director of a new cross-campus center at Duke University for integrated health data science. “This center, which has not yet been formally named,