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
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of a Watson Pharmaceutical ANDA for oxycodone hydrochloride and ibuprofen tablets, indicated for relieving pain. The basis for the withdrawal is that Watson has repeatedly failed to submit the required bioequivalence data necessary to demonstrate the bioequivalence of its drug product. To view
Drugs
FDA has approved a Genentech supplemental BLA for its triple combination of Tecentriq (atezolizumab) plus Cotellic (cobimetinib) and Zelboraf (vemurafenib) for treating BRAF V600 mutation-positive advanced melanoma patients. The agency’s review was conducted under Project Orbis, an FDA Oncology Center of Excellence program that provides a framework for
FDA Policy/General
Federal Register notice: FDA is developing a list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need for use in drug compounding, and it identifies four bulk drug substances that FDA has considered and proposes to include on its list: diphenylcyclopropenone, glycolic acid, squaric acid
Biologics
Bristol Myers Squibb and Bluebird Bio have re-filed their BLA for idecabtagene vicleucel, indicated for treating patients with heavily pre-treated relapsed and refractory multiple myeloma. In May, FDA sent a refusal to file letter, telling the company that the BLA’s chemistry, manufacturing and control (CMC) module requires
Drugs
Catalyst Pharmaceuticals says that a Florida magistrate judge has ruled in favor of FDA in the company’s lawsuit against the agency for approving competitor Jacobus Pharmaceutical’s Ruzurgi (amifampridine) for treating the rare disorder Lambert-Eaton Myasthenic Syndrome. Catalyst had argued that its orphan drug exclusivity on a competing
Devices
FDA has granted Ethicon a breakthrough device designation for its transbronchial microwave ablation technology using robotic-assisted bronchoscopy. “Our acquisitions of NeuWave Medical and Auris Health have enabled us to bring two best-in-class platforms together as we work to develop this breakthrough technology,” the company says. The NeuWave
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products.” The document describes the circumstances under which FDA generally does not intend to take action regarding required stability studies for unit-dose repackaged solid oral dosage form
Biologics
FDA has accepted from Merck two supplemental BLAs for Keytruda (pembrolizumab). One submission seeks accelerated approval for Keytruda in combination with chemotherapy for treating patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1. The user fee review action target date is 11/