Drugs
FDA has released the form FDA-483 issued following a 7/25-8/2 inspection at the Aurobindo Pharma active pharmaceutical ingredient manufacturing facility in Andhra Pradesh, India. The observations were: * procedures for the cleaning and maintenance of equipment are deficient regarding the removal or obliteration of the previous batch
Devices
FDA has cleared a Conformis 510(k) for its Acter Hip System to add a tri-taper femoral stem design to the device portfolio. The tri-taper design is intended to allow a less intrusive surgical approach, which is similar to direct anterior procedures, the company says, allowing easier access
Devices
FDA has denied a 5/3/21 petition submitted by Janice Lintz, a self-described hearing loss consultant and advocate, who asked that the agency “standardize the naming of hearing aid features and develop a rating system using international ANSI standards for various hearing aid features.” The denial letter says
Drugs
FDA says it is joining the National Institutes of Health in launching the Critical Path for Rare Neurodegenerative Diseases, a public-private partnership to advance the understanding of neurodegenerative diseases and foster the development of treatments for amyotrophic lateral sclerosis and other such diseases. An announcement says the two agencies
Drugs
CDER director Patrizia Cavazzoni has removed Bob Temple’s deputy Center director title and renamed him senior advisor for clinical science within her immediate office. Temple’s previous deputy position no longer exists in Cavazzoni’s current office structure. Asked whether the new title represents a significant change in his
Drugs
CDER has issued a Manual of Policies and Procedures (MAPP) on how it determines whether a current CDER special government employee (SGE) can represent a sponsor before FDA about a specific application. The MAPP says CDER SGEs may, under some circumstances, legally represent sponsors in meetings with FDA. “Although such
Drugs
CDER is planning a guidance document on the modernization of clinical trial conduct that is rooted in challenges to the clinical trial ecosystem brought on by the Covid-19 public health emergency. While Covid-19 disrupted traditional clinical trial infrastructures and operational activities, it also accelerated the adoption of modern
Devices
Medtronic has recalled (Class 1) its Xomed NIM Contact Reinforced Electromyogram (EMG) Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tubes after receiving customer complaints about tube obstructions while in use in patients. “If the tube obstructs, ventilation failure can occur,” a recall notice says. "If the tube
Drugs
FDA has released the FDA-483 that was at the center of an Alvotech-received complete response letter (see earlier story) on its biosimilar BLA for AVT02, a monoclonal antibody that was being evaluated for biosimilarity and interchangeability to Abbott’s Humira (adalimumab). The letter cited inspection deficiencies at Alvotech&
Drugs
A 10/18/21-11/2/21 FDA inspection at Texas Longhorn RX’s Vita Pharmacy, doing business as Talon Pharmacy of Boerne, Boerne, TX, found “serious deficiencies” in the company’s practices for producing drug products intended or expected to be sterile. An 8/29 Warning Letter cites these
Drugs
FDA has awarded a $2 million grant to Marker Therapeutics to support its Phase 2 ARTEMIS trial of MT-401, its lead multi-tumor associated antigen T-cell product candidate, in patients with post-transplant acute myeloid leukemia (AML). The company says the grant will support the treatment arm evaluating
Drugs
The Alliance for Pharmacy Compounding (APC) has submitted a letter to FDA signed by about 2,000 prescribers of compounded hormones asking that the agency assure continued patient access to compounded hormone therapy. The letter is an effort to counter what APC says is a “flawed 2020 report FDA commissioned
Drugs
FDA has issued a final rule specifying the deadline and content for submitting an annual summary of investigational drugs supplied under the Right to Try Act of 2017 and the uses for which the investigational drugs were supplied. The rule implements a provision in the Right to Try Act that
Biologics
The International Society for Cell & Gene Therapy (ISCT) says a recent California federal court ruling in favor of the California Stem Cell Treatment Center and against FDA “is flawed and has inserted regulatory uncertainty into the cell and gene therapy market, creating opportunities for clinics offering purported treatments that
Drugs
FDA says it has launched a new Web page to highlight the most recent research activities of CDER’s Office of New Drugs (OND). The Web page says OND created its research program in 2019 to foster regulatory science research (RSR). “OND-led RSR projects are designed to address knowledge
Drugs
FDA has published a report estimating cost savings from the 2,400 new generic drug approvals in 2018, 2019, and 2020. It says generic drugs approved in 2018 yield annual savings of $17.8 billion, with $4 billion from first-generic approvals. Savings from 2019 approvals amount to $24.8
Drugs
Liaisons from CDER will be part of a new In Vitro Pharmacology Working Group being assembled by Pistoia Alliance, a global not-for-profit that says it advocates for greater collaboration in life sciences research and development. The alliance says the working group also will have representatives from biopharmaceutical companies,
FDA Policy/General
Congressional negotiators are continuing to work on legislation to reauthorize FDA user fees. A Politico online newsletter reports that the Democratic and Republican leadership in the House Energy and Commerce Committee and Senate HELP Committee had aimed to reach a deal on 9/12, but talks have been extended to
Drugs
FDA has denied a Braintree citizen petition that asked it not to approve any NDA or ANDA for a tablet-based or tablet-containing colonoscopy preparation unless it contains a specification ensuring that the tablet formulation will not inhibit or interfere with the colonoscopy procedure. The petition said Braintree’s
Devices
FDA has released a draft guidance entitled “Computer Software Assurance for Production and Quality System Software.” The document describes a risk-based approach for “computer software assurance” to establish confidence in the automation used for production or quality systems, and to identify where more stringent controls may be appropriate. It
Drugs
FDA has approved a Bristol Myers Squibb NDA for Sotyktu (deucravacitinib), which is said to be a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Approval is based on data
Biologics
BioMarin Pharmaceutical says it reported an adverse event to FDA about a patient participating in the company’s hemophilia A Phase 3 gene therapy trial of valoctocogene roxaparvovec (BMN 270) being diagnosed with B-cell acute lymphoblastic leukemia. “Based on BioMarin’s assessment of the case to date, including initial