Drugs
FDA and the Duke-Margolis Center for Health Policy will hold a 7/13-14 virtual public meeting to explore potential approaches to developing a high-quality real-world data (RWD) ecosystem. The meeting will discuss “technical challenges and cultural barriers to the scalability of data capture processes, as well
Drugs
FDA has published two guidances to address drug development programs for community-acquired bacterial pneumonia and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The documents do not discuss the general issues of statistical analysis or clinical trial design that are addressed in other guidances. The guidances’ contents are
Drugs
A 4/23-4/25/18 FDA inspection at Home Care Pharmacy of Palm Coast, Palm Coast, FL, found deficiencies in the firm’s practices for producing drug products. A just-released 5/4 letter says the deficiencies involved drug compounding regulations and adulterated drug products. The letter says FDA
Devices
FDA has granted preCardia, Inc., a breakthrough device designation for its catheter-based system for treating volume overload in patients with acutely decompensated heart failure (ADHF). The device is intended to rapidly reduce congestion in the venous system, known as cardiac preload, thereby improving overall cardio-renal function, the company
Devices
FDA says it is not aware of an antibody test that has been validated for diagnosing SARS-CoV-2 infection. Writing in a special MedWatch safety alert, the agency says that while it remains open to receiving the submission of tests for such use, based on the underlying scientific principles
Drugs
FDA has lifted a partial clinical hold against an Innate Pharma Phase 2 clinical trial (TELLOMAK) that is evaluating the efficacy and safety of lacutamab (formerly IPH4102) in patients with advanced T-cell lymphomas. FDA’s action is based on a quality assessment of a new GMP-certified batch that
Drugs
CBER has updated its list of guidance documents it plans to issue in 2020. The list totals 28 guidances, including one on “Interacting with the FDA on Complex and Innovative Clinical Trial Designs for Drugs and Biological Products,” and another on “Chemistry, Manufacturing, and Controls Changes to an Approved Application:
Drugs
Public Citizen is petitioning FDA to require a Boxed Warning for all sodium-glucose cotransporter-2 (SGLT-2) inhibitor drugs contraindicating their use in patients with Type 1 diabetes. “There is irrefutable evidence from multiple randomized clinical trials that the SGLT-2 inhibitors canagliflozin (Janssen’s Invokana), dapagliflozin (AstraZeneca’s
Drugs
FDA has accepted for review a Mayne Pharma Group NDA for E4/DRSP (estetrol and drospirenone) for preventing pregnancy. The submission includes data from two Phase 3 clinical studies conducted in more than 3,725 women aged 16 to 50 years. A review action is expected in the first half
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 12 ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed and requested that they be withdrawn. To view the notice, click here.
Drugs
An 11/13-12/3/19 FDA inspection at Nanobots Healthcare, doing business as Assurance Infusion, Houston, TX, identified serious deficiencies in the firm’s practices for producing sterile drug products, which put patients at risk. A 6/12 Warning Letter acknowledges that the company ceased sterile compounding 12/19/
Drugs
A 10/15-11/8/19 FDA inspection at BHP Holdings, doing business as BioPure Healing Products, Woodinville, WA, found serious violations of the Federal Food, Drug, and Cosmetic Act and applicable regulations for dietary supplements. A 6/17 Warning Letter says the company failed to review all product complaints
Drugs
Due to an inspection moratorium, FDA has issued Nabriva Therapeutics a complete response letter (CRL) on its NDA resubmission seeking marketing approval of Contepo (fosfomycin) for injection for treating complicated urinary tract infections, including acute pyelonephritis. In 5/2019, FDA sent the company its first complete response letter, citing issues
Biologics
The Informed Consent Action Network is petitioning FDA to require placebo controls in all Phase 2 and 3 trials of vaccines against Covid-19. The group’s petition says the placebo should be a saline injection with nothing added. It calls for the placebo control group to be of at
FDA Policy/General
Two George Mason University Mercatus Center researchers say FDA’s food regulation responsibilities should be given to the Agriculture Department or some other entity to focus FDA efforts just on regulating medical products. In an online opinion column for The Hill, the researchers suggest that FDA has failed dramatically in
FDA Policy/General
Federal Register notice: FDA has determined that Promius Pharma’s Tenex (guanfacine HCl) tablets, 1mg, 2mg,and 3mg were not withdrawn from sale for reasons of safety or effectiveness. The determination allows FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal
FDA Policy/General
FDA commissioner Stephen Hahn says the agency “has maintained the same pace of meeting its goals on review of applications for medical products during the pandemic that it has maintained in recent years.” Writing in an online post to praise agency staff for their efforts, Hahn says FDA is on
Biologics
Democratic leaders of the House Committee on Oversight and Reform are calling on FDA commissioner Stephen Hahn to take steps now to ensure complete transparency in the development, review, and deployment of any Covid-19 vaccines. In a 6/18 letter, the committee leaders said the best way to bolster
Drugs
Attorneys Allison Fulton and Julia Kadish (SheppardMullin) say a 6/19 FDA guidance advising manufacturers of drugs, biologics, and active pharmaceutical ingredients on manufacturing controls to prevent contamination of drugs with SARS-CoV-2 suggests additional manufacturing controls such as vigilant monitoring and employee exclusion, more frequent cleaning and sanitizing,
FDA Policy/General
Federal Register notice: FDA has determined that dextrose in plastic container injectable, 30g/100mL, 40g/100mL, 60g/100mL, and 70g/100mL, were not withdrawn from sale for reasons of safety or effectiveness. The determination will allow the agency to approve ANDAs for such generic products. To view the notice, click
Devices
FDA has approved a Mainstay Medical Holdings PMA for ReActiv8, an implantable neurostimulation system to treat intractable chronic low back pain. Approval was based on clinical data demonstrating that the device therapy provides “progressive improvements in pain and disability over time, both in magnitude of effect and the proportion of
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. BHP Holdings, Woodinville, WA (6/17): FDA inspected the company 10/2019 and cited GMP violations for dietary supplements. For example, BHP failed to review all product complaints to