FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act. The document addresses the process through which registrants of drug establishments should submit to FDA reports on the amount of
FDA Policy/General
Federal Register notice: FDA is seeking public comments on a proposed information collection entitled “Text Analysis of Proprietary Drug Name Interpretations.” As part of the prescription drug regulatory review process, sponsors propose proprietary names for their products, and this proposed research is intended to help the agency determine whether names
Devices
Datascope/Getinge/Maquet is recalling its Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump (IABP) battery packs due to a battery failure risk. Substandard batteries can shorten run-time, which may cause the device to stop working when operated by battery only, a recall notice says. “If a patient requires life-
Drugs
A former Aegerion Pharmaceuticals sales rep has been sentenced to 54 months in prison for using the identities of physicians to carry out insurance fraud to help meet his performance bonuses. Mark Moffett (Springfield, IL) had been convicted 12/2019 by a federal jury of nine counts of wire fraud
Drugs
Johnson & Johnson says it has settled substantially all outstanding cases against its Risperdal (risperidone) over personal injury claims that the drug can cause young men to grow breasts. Risperdal is indicated for treating schizophrenia, acute manic or mixed episodes associated with Bipolar I disorder and irritability associated with autism.
Drugs
Beginning 11/15, new requirements under the FDA-approved Clozapine Risk Evaluation and Mitigation Strategy (REMS) Program become effective to require all patients, prescribers, and pharmacies to recertify and re-enroll in the new system to prevent treatment interruptions. FDA 7/29 approved modifications to the clozapine REMS and prescribers
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 18 NDAs from multiple applicants based on their requests because the drug products are no longer marketed. To view the notice, click here. To view the notice, click here.
FDA Policy/General
China’s Shandong Weigao Group Medical Polymer Co. has agreed to acquire U.S.-based Argon Medical Devices Holdings Inc. for $850 million. Weigao is involved in the production and sale of medical devices, orthopedic and blood purification products, and it has been seeking opportunities to grow its product portfolio.
FDA Policy/General
DEVICES FDA has cleared a NOWDiagnostics 510(k) for the AdexusDx hCG point-of-care test, which uses a single drop of capillary or whole blood to quickly and accurately diagnose pregnancy earlier than urine-based tests. The immunoassay is intended for use for the qualitative detection of human chorionic
Biologics
FDA 10/29 authorized the emergency use of Pfizer-BioNTech’s Covid-19 vaccine in children ages five through 11 years. The agency’s decision follows a 10/26 vote by its Vaccines and Related Biological Products Advisory Committee to recommend the agency authorize the lower-dose vaccine in the
FDA Policy/General
FDA is poised to get an additional $300 million for improving infrastructure under a revised House reconciliation bill that “reflects a top-line consistent with President Biden’s endorsement of a bill about half the size of the original $3.5 trillion proposal,” according to a report by the Alliance
FDA Policy/General
Federal Register notice: FDA has announced an 11/16 public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments for fiscal years 2023 through 2027. To view the notice, click here.
FDA Policy/General
Federal Register notice: Health and Human Services is proposing to withdraw or repeal a final rule entitled “Securing Updated and Necessary Statutory Evaluations Timely” (SUNSET) that was published 1/19. The SUNSET final rule was scheduled to take effect 3/22. However, on 3/9 a lawsuit was filed seeking
Drugs
FDA has announced the availability of a “NextGen Portal” for reporting the annual amount of listed human and animal drugs and human biological products that an establishment manufactured, prepared, propagated, compounded, or processed (including repacking and relabeling) for commercial distribution. All registrants of drug establishments or their authorized agents should
Devices
Zimmer Biomet has recalled its Rosa One 3.1 Brain Application, a robotic platform that helps neurosurgeons with positioning medical instruments or implants during surgery, due to a software error. The device comprises a compact robotic arm and a touch screen mounted on a stand. Different types of instruments or
FDA Policy/General
Federal Register notice: FDA has announced a periodic listing of Emergency Use Authorizations (EUAs) for certain medical devices related to the Covid–19 public health emergency. The EUAs contain, among other things, conditions on the emergency use of the authorized products. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is publishing a list of information collections that have been approved by OMB. They are: * Infant Formula Requirements * Shortages Data Collection * Guidance on Labeling for Natural Rubber Latex Condoms * Section 513(g) Requests for Information To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has issued a priority review voucher to Enzyvant Therapeutics in response to its approval of a qualified rare pediatric disease product application. The agency determined that the company’s Rethymic (allogeneic processed thymus tissue-agdc), indicated for immune reconstitution in pediatric patients with congenital athymia, meets
Drugs
In a sweeping HHS announcement of the Biden administration’s strategy for curbing drug overdoses, secretary Xavier Becerra said one element in the plan is to expand the number of doctors who can prescribe buprenorphine to treat addiction, bypassing rules requiring hours of training for the physicians. The Washington Post
FDA Policy/General
FDA says the CDER Office of Prescription Drug Promotion is proposing to investigate the influence of targeted mechanism of action claims, graphics, and disclosures that provide context about a drug’s targeted mechanism of action in both consumer and healthcare professional promotions. A Federal Register notice says the research will
Biologics
An estimated 30 million to 50 million doses of Johnson & Johnson’s Covid vaccine made early this year are in storage at the Emergent BioSolutions facility in Baltimore waiting for FDA approval to ship, according to a Reuters report. The news service says it was informed by two sources
Devices
FDA has cleared a NeuroLogica 510(k) for its Auto Lung Nodule Detection (ALND) tool, a computer-assisted detection solution for detecting pulmonary nodules from 10 to 30mm in size through an artificial intelligence algorithm. It is designed to aid physicians in reviewing adult posteroanterior chest radiographs, the company says.