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 In a comment on an agency draft guidance on considerations for a benefit/risk assessment framework for opioids, the company says it agrees with FDA that an assessment of opioid analgesic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
FDA Policy/General
Federal Register notice: FDA has reopened the comment period for a 3/1 notice entitled “International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization; Scheduling Recommendations; Dronabinol (delta-9 tetrahydrocannabinol) and its Stereoisomers; Cannabis, Cannabis Resin, Extracts and Tinctures; Cannabidiol Preparations; and Pharmaceutical Preparations
Devices
FDA has cleared a Biobeat 510(k) for its patch and watch for measuring blood pressure, oxygenation and heart rate in hospitals, clinics, long-term care and at home. The company’s smartwatch and patch connect to the cloud through either a smartphone or a dedicated gateway. Users can wear
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. CTX Lifesciences, Gujarat, India (7/12): FDA inspected the firm in February and cited significant GMP deviations for active pharmaceutical ingredients (API). For example, CTX failed to ensure that
FDA Policy/General
Attorney Anne Walsh (Hyman, Phelps & McNamara) says a recent Supreme Court decision “significantly cabined the scope and application” of what is known as the Auer deference, which requires courts to defer to FDA’s interpretation of its own regulations if they are ambiguous. Writing in her firm’s FDA
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Male Breast Cancer: Developing Drugs for Treatment.” The document provides recommendations on the development and labeling of cancer drugs for treating male patients with breast cancer. It also provides recommendations on clinical development when males have either not been
Drugs
A recently posted Establishment Inspection Report (EIR) on AveXis’ Zlogensma, a gene therapy product associated with data manipulation allegations, shows an extensive review of a controversial in vivo potency assay (SOP-285) and FDA’s acceptance that problems raised with the assay have been resolved with its discontinuance and the
Drugs
CDER Office of Antimicrobial Products (OAP) director Edward Cox has left FDA to join Regeneron as regulatory affairs vice president. Cox has served as OAP director since 2006, after serving as its deputy director since 2003. OAP deputy director John Farley will serve as acting director until a permanent replacement
Devices
FDA has given Staar Surgical IDE approval to begin a clinical trial for the EVO/EVO+ VISIAN Implantable Collamer Lens for myopia, and EVO/EVO+ VISIAN Toric Implantable Collamer Lens for myopia with astigmatism. Under the IDE, FDA recommended study design modifications, which Staar says it plans to incorporate into