FDA Policy/General
DEVICES FDA has cleared a Surgical Innovation Associates 510(k) for DuraSorb Monofilament Mesh, a line of bioabsorbable technologies for reconstructive and cosmetic surgery. “Much like an absorbable stitch, DuraSorb Monofilament Mesh is designed to integrate into the patient’s tissue – providing strong support during the critical initial phases of
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision for a guidance entitled “Postmarketing Adverse Experience Reporting and Recordkeeping for Drug and Biologics Products” (OMB Control Number 0910-0230). The collection supports statutory provisions regarding the monitoring of FDA-regulated products. The guidance was revised to provide
FDA Policy/General
Federal Register notice: FDA is amending the animal drug regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during April, May, and June. The agency is also making available the basis of approval and environmental review documents, where applicable. To view the
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Establishments: Questions and Answers. The document provides recommendations for implementing a pathogen reduction device when manufacturing pathogen-reduced blood components. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Content of Premarket Submissions for Device Software Functions. The document is intended to provide information regarding the recommended documentation sponsors should include in premarket submissions for the agency to evaluate device software functions. To view the notice, click here.
Drugs
A lengthy Reuters series on the U.S. battle against diabetes says the treatment goal to lower A1c below 7% pushed by makers of diabetes drugs is leading to cases of hypoglycemia that have significant adverse effects and can lead to death. “Pharmaceutical giants launched years-long marketing campaigns for
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Novartis’ Adakveo (crizanlizumab-tmca), indicated to reduce the frequency of vaso-occlusive crises in adults and pediatric patients with sickle cell disease. The review period is 3,152 days, which includes 2,968 days that
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Sanofi’s Dengvaxia (dengue tetravalent vaccine, live), indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4. The review period is 5,710 days, which includes 5,466
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Galderma’s Aklief (trifarotene), indicated for topical treatment of acne vulgaris in patients nine years of age and older. The review period is 3,137 days, which includes 2,771 days that occurred during the
FDA Policy/General
After almost 20 years at FDA, chief scientist and Public Health Service Commissioned Corps rear admiral Denise Hinton has left the agency to serve as deputy Surgeon General under the Biden Administration. Hinton previously worked at CDER before transitions to the Office of Commissioner as chief scientist. At CDER, Hinton
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Sarepta Therapeutics’ Vyondys 53 (golodirsen), indicated for treating Duchenne muscular dystrophy. The review period is 1,833 days, which includes 1,474 days that occurred during the testing phase and 359 days during the approval
FDA Policy/General
Federal Register notice: FDA has determined for patent restoration purposes the regulatory review period for Biogen’s Spinraza (nusinersen sodium), indicated for treating spinal muscular atrophy in pediatric and adult patients. The review period is 1,891 days, which includes 1,799 days that occurred during the testing phase and
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki), indicated for treating adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic
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
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
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
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