Drugs
A new Government Accountability Office (GAO) report recommends that FDA better track the extent of its efforts to encourage drug manufacturers to adopt advanced manufacturing. The report was mandated by the CARES Act to report on the federal pandemic response, particularly FDA’s efforts to support advanced manufacturing as a
Drugs
FDA has published a Federal Register notice outlining the status of the many guidance documents that were issued to address the Covid-19 public health emergency (PHE), which will officially end 5/11. Because many of the guidance documents issued during the PHE to address Covid-19 were tied to
Drugs
FDA has split into two its guidance entitled “Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised).” The two new guidances have no changes to the agency’s enforcement policy, and the action is intended
Drugs
FDA has approved a Pfizer NDA for Zavzpret (zavegepant), the first calcitonin gene-related peptide receptor antagonist nasal spray for treating adults with acute migraine headache with or without aura. Approval was based on data from a Phase 3 study that showed Zavzpret was statistically superior to placebo on the
Devices
A 3/8 letter from 18 Republican senators is urging HHS to abandon a Medicare pricing model that aims to balance incentives for developing novel treatments under FDA’s accelerated approval program (AAP) with potential harms of delayed confirmatory clinical trials. According to an HHS report (begins pg. 14), the
Devices
Baxter International says it has issued an “urgent medical device correction” for its Life2000 Ventilation System due to the “potential for patient oxygen desaturation (low blood oxygen) events that can occur under certain conditions” when the device is connected to a third-party oxygen concentrator.” The Life2000 system is manufactured
Biologics
FDA has approved a Coherus BioSciences BLA for a single-dose, prefilled autoinjector presentation of its Udenyca (pegfilgrastim-cbqv), a biosimilar of Amgen’s Neulasta that is administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia. “The introduction of the autoinjector option for
Drugs
Four FDA and European Medicines Agency staffers who work in the joint parallel scientific advice (PSA) program say their evaluation of program activity from 2017 through 2021 demonstrated its value to product sponsors and the two agencies. Writing in Therapeutic Innovation and Regulatory Science, the four say the program “provides
Drugs
Lilly says it is ending clinical development of solanezumab for preclinical Alzheimer’s disease due to disappointing results from the Phase 3 A4 study that was launched in 2013. The company reports that the drug failed to meet its primary or secondary endpoints in that it did not slow cognitive
Biologics
FDA commissioner Robert Califf says truth is “losing the [misinformation] battle right now” and FDA and many other stakeholders can and must do more to try to protect people from medical misinformation. In an interview with the online newsletter Stat News, Califf said the agency may need to update its
Drugs
FDA’s just-released budget request for FY 2024 has the agency seeking a $372 million (10%) boost and a $150 million increase in user fees. The total funding being proposed for FDA, including $3.5 billion in total user fees, is $7.2 billion. “This funding will allow the
Drugs
AstraZeneca says data from its ADAURA Phase 3 trial showed that its lung cancer drug Tagrisso (osimertinib) demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to placebo in the adjuvant treatment of patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung
Devices
The Department of Justice says former Stimwave CEO Laura Perryman was named in a two-count indictment in connection with a scheme to create and sell a non-functioning dummy medical device for implantation in patients suffering from chronic pain, resulting in millions of dollars of losses to federal healthcare
Drugs
FDA has approved an Amphastar NDA for naloxone hydrochloride nasal spray 4mg, which is delivered using the company’s proprietary nasal delivery device. A company statement says the naloxone spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous
Devices
CDRH director Jeff Shuren has taken the unusual step of addressing a company’s criticism directed at his Center’s alleged delay in granting an emergency use authorization (EUA) as a “misinformation” correction under FDA commissioner Robert Califf’s initiative to curb half-truths and misinformation that “pose enormous dangers
Devices
FDA has updated its mammography regulations to require mammography facilities to notify patients about the density of their breasts. An agency notice says the update also strengthens the agency’s oversight and enforcement of facilities and enables FDA to help doctors better categorize and assess mammograms. The notice says advising
Drugs
The Natural Products Association and the Alliance for Natural Health have petitioned FDA to determine that nicotinamide mononucleotide (NMN) is not excluded from the definition of a dietary supplement. A statement from the two associations (contains a link to the citizen petition) says the groups also want the agency to:
Drugs
FDA has accepted for review a BioMarin sBLA seeking an expanded indication for its Voxzogo (vosoritide) for injection to treat children under age 5 with achondroplasia. The agency set a PDUFA target action date of 10/21. The company says the sBLA is supported by results from a Phase 2
Drugs
Covis Pharma says it remains willing to voluntarily withdraw its pre-term birth drug Makena (hydroxyprogesterone caproate injection) and to work with CDER on an orderly wind-down. In a 3/6 letter to FDA commissioner Robert Califf and chief scientist Namandjé Bumpus, responding to the 1/19 report of
Drugs
The FDA Oncology Center of Excellence (OCE) has published a patient-focused glossary of 37 terms to aid patients in understanding complex clinical trial terminology. Writing in The Oncologist, six OCE staff members describe the process OCE took to develop the glossary. “The oncology clinical trial terms and definitions used
Drugs
The United States Pharmacopeia (USP) has launched a Nitrosamines Analytical Hub, the latest tool in its suite of solutions to address the evolving nitrosamines crisis. USP describes the tool as a public, Web-based repository of downloadable analytical procedures to test for nitrosamine impurities and related substances in pharmaceuticals. The
FDA Policy/General
FDA has released the FY 2022 annual inspection metrics for the compliance programs within the agency’s Bioresearch Monitoring (BIMO) program. BIMO inspections (domestic and foreign) were conducted by the Office of Regulatory Affairs, except for a portion conducted by CDER subject matter experts. According to the metrics, the most