Drugs
Barely a week after he called for public input on the problem, a group of senators have urged FDA commissioner Scott Gottlieb to address prescription drug costs by curbing abuses by drug companies to delay competition. Senator Dianne Feinstein (D-CA) joined a bipartisan group of Senate Judiciary Committee members
Drugs
GMP issues cited during a 2016 inspection at Pfizer’s McPherson, KS manufacturing facility (Hospira) have led to a a complete response letter on a BLA for a proposed biosimilar referencing Amgen’s Epogen/Procrit (epoetin alfa). A Warning Letter was issued 2/14 (see earlier story) after FDA conducted
FDA Policy/General
Federal Register notice: FDA has announced an 8/2 Arthritis Advisory Committee meeting to discuss a Janssen Biotech BLA for Plivensia (sirukumab injection). The submission is seeking approval for treating adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or are intolerant to one
Drugs
FDA commissioner Scott Gottlieb says he would like to make redacted complete response letters publicly available. Patient groups and certain other stakeholders have been asking the agency for years for more information when the agency rejects an NDA or BLA. And now-retired CDER Office of New Drugs director John
Drugs
FDA’s Generic Drug User Fee Amendments of 2012 (GDUFA) program had a $174 million carryover in fiscal year 2016, but it lacked a plan for administering this carryover — “one that includes a fully-documented analysis of program costs and risks to ensure that program operations can be sustained in
FDA Policy/General
Public Meeting Planned on Alopecia Drug Development Federal Register notice: FDA announces a 9/11 public meeting on “Patient-Focused Drug Development for Alopecia Areata.” 06/23/2017 Nominations Sought for Device GMP Panel Members Federal Register notice: CDRH seeks nominations for voting members to serve on the Device Good
FDA Policy/General
Federal Register notice: FDA is seeking comments on a submission involving proposed recommendations for industry on developing continuous manufacturing for solid dosage drug products. The Center for Structured Organic Particulate Systems (C-SOPS) recently submitted an industry-coordinated best practices document on continuous manufacturing. FDA is interested in public comments
Drugs
“Big Pharma has captured the Trump administration.” That is the bottom line in a Public Citizen analysis of a draft executive order on prescription drug pricing and innovation that president Trump is expected to soon sign. The analysis echoes concern from experts who talked to the New York Times earlier
Biologics
FDA has approved a CSL Behring BLA for Haegarda, the first C1 esterase inhibitor (human) for subcutaneous administration to prevent hereditary angioedema (HAE) attacks in adolescent and adult patients. “The subcutaneous formulation allows patients to administer the product at home to help prevent attacks,” an FDA release says. Haegarda is
Drugs
An Indiana compounding pharmacy owner and compliance director have been charged criminally in connection with their distribution of over- and under-potent drugs, and defrauding the U.S. by interfering with and obstructing FDA’s lawful duties, according to the Department of Justice (DoJ). Pharmakon Pharmaceuticals’ Paul J. Elmer (Fishers,
Devices
FDA has approved a Roche PMA for its fourth-generation HIV combination antigen-antibody assay, the Elecsys HIV combi PT assay. The assay is intended for the in vitro qualitative determination of HIV-1 p24 antigen and antibodies to HIV-1 (HIV-1 groups M and O) and HIV-2
FDA Policy/General
Federal Register notice: FDA has announced a 9/11 public meeting on “Patient-Focused Drug Development for Alopecia Areata.” The meeting will allow the agency to obtain patients’ perspectives on the impact of alopecia areata, including on daily life. It is also seeking patients’ views on treatment approaches and decision
FDA Policy/General
Federal Register notice: CDRH is seeking nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee and device panels of the Medical Devices Advisory Committee. Nominations received on or before 8/22 will be given first consideration for membership on the panels. To view the notice,
Drugs
FDA has approved a Portola Pharma NDA for Bevyxxa (betrixaban) for preventing venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE. An FDA notice says the most
Drugs
The U.S. Chamber of Commerce says that a survey sponsored by its Institute for Legal Reform shows that 25% of Americans taking certain prescribed medicines say they would stop taking the drugs immediately without consulting their doctor after seeing ads promoting lawsuits against the drugs’ manufacturers. The Chamber says
Drugs
FDA says it has established a public docket to invite discussion of issues related to adoption of continuous manufacturing by the drug industry. A Federal Register notice to be published 6/23 says that the agency agreed during a 5/7/15 workshop on the future of pharmaceutical manufacturing that
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 121 NDAs and 161 ANDAs from multiple applicants. The application holders notified the agency that the drug products were no longer marketed and requested that the approvals be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 7/18 public meeting on “‘The Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access.” The meeting is seeking comments on the administration of the Hatch-Waxman Amendments to help ensure the intended balance between encouraging innovation in drug development and accelerating
Drugs
FDA has granted Zogenix an orphan drug designation for its investigational drug, ZX008 (low-dose fenfluramine), for treating Lennox Gastaut Syndrome (LGS), a refractory, debilitating childhood-onset epilepsy. An IND was approved in April for a Phase 3 LGS study involving the drug. Zogenix is currently conducting a Phase 3
Drugs
[This report has been updated to remove incorrect attribution.] Starting early next year, FDA will begin encouraging a voluntary quality metrics reporting program to calculate three metrics, CDER Office of Surveillance acting director Sarah Pope Miksinski told a Drug Information Association (DIA) session in Chicago 6/21. Late last year,
Devices
FDA has cleared an Insulin Algorithms 510(k) for its decision-support software, which helps clinicians manage every type of insulin for diabetes treatment. The company says the software makes it easy for a clinician to regularly analyze a patient’s blood sugar measurements and quickly optimize the insulin regimen.
Drugs
CDER has issued a Manual of Policies and Procedures (MAPP) establishing policies and procedures for review staff in the Office of New Drugs for the review and management of financial disclosure information submitted in NDAs and BLAs and supplements to them. A 1998 final rule “is intended to ensure that