Devices
FDA has granted Concept Medical a “breakthrough device designation” for MagicTouch AVF, a sirolimus drug-coated balloon (DCB) catheter for percutaneous transluminal angioplasty treatment of stenotic lesions related to arteriovenous (AV) fistulae or AV arteriovenous grafts in patients undergoing hemodialysis treatment due to renal failure. The company says “preliminary data
Drugs
FDA has granted Akari Therapeutics an orphan drug designation for nomacopan and its use in treating hematopoietic stem cell transplantation-associated thrombotic microangiopathy (HSCT-TMA). Orphan status follows a fast track designation given earlier this month for the same indication in pediatric patients. The company says it is planning a
FDA Policy/General
Federal Register notice: FDA has determined the regulatory review period for patent extension purposes for Puma Bio’s Nerlynx (neratinib), indicated for extended adjuvant treatment of adult patients with early stage HER2- overexpressed/amplified breast cancer. The review period was 5,102 days, which includes 4,738 days that occurred
FDA Policy/General
FDA acting commissioner Ned Sharpless may be on the out as President Trump has not nominated him to be the permanent agency head, and under the Federal Vacancies Reform Act of 1998 he can only serve in a Senate-confirmed position for a maximum of 210 days, which would give
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) posted 8/12 an on-demand Webinar discussing elements of the 6/24 final guidance on providing promotional labeling and advertising materials in electronic and non-electronic format. OPDP lead project manager Jason Cober discussed the 24-month transition period for promotional
FDA Policy/General
Federal Register notice: FDA has extended the submission period related to a 6/29 notice on “Modernizing Pharmaceutical Quality Systems; Studying Quality Metrics and Quality Culture; Quality Metrics Feedback Program.” Submissions are now being accepted until 12/30. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products.” The document finalizes an 8/24 draft guidance entitled “Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical
Drugs
AstraZeneca says that the Phase 3 TULIP 2 trial for anifrolumab, an investigational drug for treating systemic lupus erythematosus (SLE), met its primary endpoint — “achieving a statistically-significant and clinically-meaningful reduction in disease activity versus placebo, with both arms receiving standard of care.” The reduction, it says, “was measured
Drugs
Collegium Pharmaceutical, a specialty pain management drug company, says it appreciates recent FDA actions related to the opioid crisis. In a comment on an agency draft guidance on considerations for a benefit/risk assessment framework for opioids, the company says it agrees with FDA that an assessment of opioid analgesic
Devices
FDA has issued a safety alert that recommends healthcare providers transition to duodenoscopes with innovative designs that are safer and eliminate the need for reprocessing. The agency is also mandating new postmarket surveillance study orders to manufacturers of duodenoscopes with disposable endcaps to gather more information and verify that new
Devices
FDA has published two guidances relating to making benefit/risk determinations in certain medical device applications. The first guidance, Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions, describes the agency’s current approach to considering uncertainty in making
Drugs
FDA has released the FDA-483 issued following an 8/12-8/20 inspection at the Dr. Reddy’s Laboratories drug manufacturing facility in Andhra, Pradesh, India. The inspection observations were: * the quality control unit lacks authority to fully investigate errors that have occurred; * procedures designed to prevent microbiological contamination
Drugs
FDA has granted Emalex Biosciences a fast track designation for its investigational drug ecopipam for treating patients with Tourette Syndrome (TS). Ecopipam selectively blocks the actions of dopamine at the D1 receptor, the company says. Previous Phase 2 studies in both adult and pediatric patients have “suggested potential activity in
Drugs
FDA has released a final guidance entitled “Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products.” The document provides recommendations to industry about placebos and blinding in development programs for products to treat hematologic malignancies and oncologic diseases. It does not address the statistical analyses
Biologics
FDA has accepted for review a Viela Bio BLA for inebilizumab, an investigational anti-CD19 monoclonal antibody for treating patients with neuromyelitis optica spectrum disorder. The rare autoimmune disease is characterized by unpredictable attacks that often lead to severe, irreparable disability including blindness and paralysis, according to the company. The
Drugs
FDA has issued a safety alert on three chronic hepatitis drugs — Abbvie’s Mavyret (glecaprevir and pibrentasvir), Merck’s Zepatier (elbasvir), and Gileadֺ’s Vosevi (sofosbuvir) — after some patients with moderate to severe liver impairment experienced worsening liver function or liver failure. All three drugs are hepatitis C virus protease
Drugs
A 7/17 CDER Workshop, “Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting Systems (FAERS) Using International Council for Harmonization E2B (R3),” laid a foundation for the agency’s transition to FAERS II, described as a different underlying architecture that will incorporate the changes the agency agreed
Drugs
Two FDA Center directors are speaking out to defend the agency’s use of expedited approval pathways. In an FDA Voices online post, CDER director Janet Woodcock and CBER director Peter Marks say the pathways “deliver promising new medicines without sacrificing safety and efficiency. FDA walks a fine line. We
Drugs
CDER director Janet Woodcock says the actual risk to patients due to contaminants in angiotensin I receptor blockers (ARBs) is likely much lower than FDA estimates that reflect a scientific assessment of the highest possible exposure. In an online statement, she says stakeholders often ask how many patients have been
Drugs
Public Citizen says an FDA proposal to use and publicly post, upon approval of an NDA or BLA, an abbreviated integrated review document in place of the more detailed individual medical, chemistry, pharmacology, statistical, clinical pharmacology, biopharmaceutics, and risk assessment and risk mitigation reviews, among others, that have been prepared
Devices
FDA has cleared a 4Web Medical 510(k) to market its Cervical Spine Truss System-Stand Alone interbody fusion device. It is designed to allow fixation screws to be placed through the truss implant and into the adjacent vertebral bodies creating a zero-profile stand-alone construct that removes the
Drugs
Pfizer says it supports an FDA 6/2019 draft guidance on drug development endpoints for treating heart failure. The company comment letter says the guidance “is positive in that large mortality trials may not be needed for a heart failure indication. Rather, based on the draft guidance, now studies could