FDA Policy/General
Federal Register notice: FDA has announced a 4/24-25 joint Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee meeting. Panel members are scheduled to discuss a Pfizer supplemental NDA for Celebrex (celecoxib) capsules and the results from the PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety
Drugs
FDA has approved Foundation Medicine’s FoundationOne CDx (F1CDx), a next generation sequencing-based in vitro diagnostic test that can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type. The sponsor says that unlike other companion diagnostics, the F1CDx is a more extensive test
Drugs
FDA has released two user fee-related implementation plans as part of the recent user fee reauthorization. The first is the “Resource Capacity Planning & Modernized Time Reporting Implementation Plan,” which outlines an approach to “develop capabilities that will help ensure that the FDA is making optimal use of its
Drugs
Sunovion Pharmaceuticals has submitted an NDA for APL-130277 (apomorphine) sublingual film, indicated for treating motor fluctuations (Off episodes) in patients with Parkinson’s disease. The NDA is supported by data from a pivotal, Phase 3 study, CTH-300, which met its primary and key secondary endpoint. In the study,
Devices
FDA’s Clinical Chemistry and Clinical Toxicology Devices Advisory Committee has voted unanimously to recommend approval of Senseonics Holdings’ Eversense, a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes. The device uses a sensor that can last up to 90 days. The company demonstrated the safety,
FDA Policy/General
Federal Register notice: FDA has announced a 5/22 joint Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee advisory committee meeting. Panel members are scheduled to discuss an Insys Development NDA for buprenorphine sublingual spray, indicated for treating moderate-to-severe acute pain
Drugs
A Government Accountability Office (GAO) review says that stakeholder organizations have mixed views about FDA monitoring of Mifeprex since its 2000 approval with an indication for the medical termination of early pregnancy. Members of Congress asked GAO to review FDA’s 2016 relabeling of Mifeprex with a revised indication and
Drugs
A New York federal judge has entered a consent decree sought by FDA against Riddhi USA, ordering the company to stop selling its products until it complies with agency dietary supplement manufacturing regulations and other conditions in the decree. An agency news release says FDA alleged that the company was
FDA Policy/General
Federal Register notice: FDA has made available a revised draft guidance on generic doxycycline hyclate oral delayed-release tablets, entitled “Product-Specific Guidance for Doxycycline Hyclate.” The document provides product-specific recommendations on bioequivalence study designs to support ANDAs for such rug products. To view the notice, click here.
Drugs
FDA has released the FDA-483 issued following a 2/12-3/5 inspection at SCA Pharmaceuticals, Windsor, CT. Inspection observations listed on the form were: * the written stability program for drug products does not include reliable and meaningful test methods; * procedures designed to prevent microbiological contamination of drug products
FDA Policy/General
Federal Register notice: FDA has submitted for OMB approval a new information collection entitled “Guidance for Industry on Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” Section 503B describes conditions that must be met
Drugs
Officials from FDA and the National Institutes of Health say it is important to develop new tools that could lead to biomarkers to determine the efficacy of drugs to combat opioid addiction. Writing in Science Translational Medicine, the officials say that the opioid crisis and overdose epidemic gripping the U.
Drugs
FDA has granted Amgen accelerated approval for Blincyto (blinatumomab) and its expanded use to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD). “Because patients who have MRD are more likely to relapse, having a treatment
Drugs
Insmed has submitted an NDA for Alis (amikacin liposome inhalation suspension), indicated for treating adult patients with nontuberculous mycobacterial (NTM) lung disease caused by mycobacterium avium complex. The filing is supported by data from the company’s pivotal Phase 3 CONVERT study conducted in subjects with refractory NTM lung disease.
Drugs
An HHS Office of Inspector General (OIG) report calls on FDA provide education to ensure that drug dispensers understand their responsibilities under the Drug Supply Chain Security Act (DSCSA) to receive complete product tracing information from trading partners before taking ownership of drug products. FDA concurs with the recommendation, the
Devices
Three industry stakeholders say they appreciate an FDA draft guidance on investigational IVDs (in vitro diagnostics) and suggest changes they would like in the draft. The Biotechnology Innovation Organization (BIO) says in a 3/19 comment letter that it appreciates that the guidance provides several examples of IVD uses that
Devices
FDA has approved a Hologic PMA for its Clarity HD high-resolution 3D imaging and Intelligent 2D imaging technology and their use on the company’s 3Dimensions breast tomosynthesis system. The company says the imaging technology provides fast high-resolution 3D images to accelerate screening and analysis, and it is
Biologics
FDA has accepted for review a Bristol-Myers Squibb supplemental BLA for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for treating adults with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan. The agency has set a user fee
FDA Policy/General
Federal Register notice: FDA has renewed for an additional two years the charter for its Gastrointestinal Drugs Advisory Committee. Authority for the advisory committee will expire 3/3/2000. To view the notice, click here.
Drugs
FDA has released a report entitled The Voice of the Patient: Alopecia Areata that summarizes a 9/2017 public meeting that heard from patients and caregivers about the symptoms and health effects that matter most to alopecia patients. The report can be used by drug developers seeking to develop therapies
FDA Policy/General
Federal Register notice: FDA has announced a 5/3 joint Gastrointestinal Drugs Advisory Committee and Pediatric Advisory Committee meeting. Panel members are scheduled to review an InfaCare Pharmaceutical NDA for stannsoporfin intramuscular injection, indicated for treating neonates greater than or equal to 35 weeks of gestational age with indicators of
Drugs
Attorney Steven Boranian (Reed Smith) says plaintiffs alleging that innovator companies failed to issue a warning after receiving “newly acquired evidence” of a risk must be able to tell what the company knew and when it knew it. Writing in a Drug and Device Law blog post, Boranian reviews a