FDA Policy/General
FDA says its 6/2020 review of the Web site operated by Fishman Chemical of North Carolina, Vero Beach, FL, found that the company sells 11 unapproved new animal drugs. A 7/21 Warning Letter also says the company is continuing to sell chloroquine phosphate, an adulterated new animal drug,
Drugs
FDA says it discontinued the MedWatch to Manufacturers program as of 7/31. Under the program, participating drug and biologic manufacturers could receive information from the agency on serious adverse event reports submitted directly to FDA for new molecular entities and original biologics for the first three years after approval,
Drugs
Public Citizen says that taxpayers invested $70.5 million in the development of Gilead’s remdesivir, which is being used to treat some Covid-19 cases, and thus the company should price the treatment at no more than $1 per day. The advocacy group cited a letter signed by a
Devices
FDA has cleared a Biotricity 510(k) for its Bioflux Software II System. The product is engineered to improve workflows and reduce electrocardiogram (ECG) analysis time from five minutes to 30 seconds, the company says. The Bioflux monitors and transmits an ambulatory patient’s ECG information. It also features “advanced
Devices
HHS secretary Alex Azar 8/4 praised FDA commissioner Stephen Hahn for developing alternative regulatory pathways that could be used to obtain face masks from foreign countries in the early days of the Covid-19 pandemic. Appearing on “Mornings with Maria” on Fox Business, Azar responded to a Wall Street
FDA Policy/General
Federal Register notice: FDA is requesting comments on abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on the availability for medical use of 11 drug substances. The comments will be considered in preparing a response from the U.S. to the World Health Organization (WHO) regarding
Biologics
FDA commissioner Stephen Hahn and deputy commissioner for medical and scientific affairs Anand Shah say the agency has sought to encourage and facilitate the adoption of “advanced manufacturing,” which they say refers to new and emerging approaches for producing medical technologies. Writing in an FDA Voices post, Hahn and Shah
Drugs
GlaxoSmithKline (GSK)and Sanofi have separately disclosed in financial reports that they are being investigated by the U.S. Justice Department over alleged False Claims Act violations in the companies’ marketing and subsequent recall of heartburn drug Zantac (ranitidine). Earlier this year, FDA asked manufacturers (see earlier story) to withdraw
Drugs
Four former FDA commissioners are urging U.S. regulators, researchers and Covid-19-recovered patients to join in an effort to collect blood plasma and begin clinical trials to determine whether the plasma from recovered patients can help those who become sick. Writing in a Washington Post opinion piece, Mark
FDA Policy/General
Federal Register notice: FDA has announced the rates for biosimilar user fees for fiscal year 2021. For example, the fee for a biosimilar application requiring clinical data is $1.7 million, and the initial biological product development fee is $102,000. To view the notice, click here.
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Acrx Specialty Pharmacy, Las Vegas, NV (7/24): FDA inspected the firm in March and found multiple violations of drug compounding and other provisions of the Federal Food, Drug,
FDA Policy/General
Federal Register notice: FDA has announced the rates for prescription drug user fees for fiscal year 2021. For example, fee for NDA/BLA requiring clinical data $2.9 million, NDA/BLA not requiring clinical data $1.4 million and the program fee is set at $336,000. To view the
FDA Policy/General
Federal Register notice: FDA has announced the fee rates and payment procedures for medical device user fees for fiscal year 2021. For example, PMA user fees are set at $365,000, 510(k) fee $12,400 and annual establishment registration fee $5,500. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans.” The document addresses FDA’s current thinking on implementing the requirement for sponsors to submit a pediatric study plan. To
FDA Policy/General
Federal Register notice: FDA has made available guidance documents related to Covid–19 public health emergency. The documents have been implemented without prior comment, but they remain open for comments in accordance with the agency’s good guidance practices. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on a report entitled “Independent Evaluation of the GDUFA Resource Capacity Planning Adjustment Methodology.” The report, which was mandated in the Generic Drug User Fee Amendments of 2017, provides options and recommendations for a new methodology to assess changes in the resource needs
Devices
FDA has updated its recognized consensus standards database for medical devices. New or revised recognized standards were added and standards that are no longer recognized were withdrawn. Other updates include revisions to some standards’ extent of recognition and transition periods. An FDA guidance, Appropriate Use of Voluntary Consensus Standards in
Drugs
A citizen petition from two groups and three individuals is asking FDA to ban music in direct-to-consumer (DTC) television, radio and internet streamed advertisements because it distracts the audience’s attention from product side effects and contraindications. Filed by Knowledge Ecology International, the Center for Digital Democracy, and
Drugs
FDA has posted a final guidance entitled “Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans.” The guidance addresses applications for which a study plan is required and the timing and content of such plans. It also provides a template
Drugs
FDA has approved a Janssen Pharmaceutical supplemental NDA for Spravato (esketamine) nasal spray, taken with an oral antidepressant, to treat depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior. Approval was based on data from two identical Phase 3 clinical trials in which Spravato plus
FDA Policy/General
Mallinckrodt has agreed to acquire InfaCare, a privately held specialty pharmaceutical company focused on developing proprietary pharmaceuticals for neonatal and pediatric patient populations. The transaction includes InfaCare’s developmental product stannsoporfin, a heme oxygenase inhibitor, for reducing the production of bilirubin, the elevation of which can contribute to serious consequences
FDA Policy/General
Federal Register proposed rule: FDA is proposing to amend its regulations to require that certain data elements be submitted for veterinary devices that are being imported or offered for import in the “automated commercial environment” or any other electronic data interchange system authorized by U.S. Customs and Border Protection