Drugs
Jubilant Cadista Pharmaceuticals (Salisbury, MD) has recalled one lot of drospirenone and ethinyl estradiol tablets due to out-of-specification dissolution results at the three-month stability time point. The affected product is made by contract manufacturer Cyndea Pharma in Soria, Spain. As a result of the dissolution results, product
Drugs
The World Health Organization (WHO) has published its draft working document QAS/19.81, Quality Management System Requirements for National Inspectorates, describing the quality management system requirements for operation of inspection services within national regulatory authorities or other state structures. WHO says it is intended that each inspection service will
Drugs
Pfizer says it appreciates the information in an FDA draft guidance on comparative analytical assessment and other quality-related considerations for developing therapeutic protein biosimilars. The company’s comment letter says it believes that combining the comparative analytical assessment within the previously issued quality considerations guidance is a very positive
Drugs
The Senate Finance Committee meets 7/25 to mark up the Prescription Drug Pricing Reduction Act of 2019, introduced by committee chairman Chuck Grassley (R-IA) and ranking member Ron Wyden (D-OR). Grassley and Wyden say the bill as drafted would result in Medicare savings of $85 billion over
Drugs
A 1/17-1/25 FDA inspection at the Indoco Remedies Limited drug manufacturing facility in Goa, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 7/9 Warning Letter says specific violations were: * failing to prepare batch production and control records with complete
Drugs
The DC federal court has vacated an FDA 12/2018 exclusivity determination that blocked Braeburn’s Brixadi (buprenorphine) extended-release injection for treating opioid use disorder from final approval through 11/30/20 due to exclusivity granted to Indivior’s Sublocade. The court told FDA to reconsider its decision “with
Drugs
A 12/17/18-2/8/19 FDA inspection at High Chemical Company, Levittown, PA, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). A 7/2 Warning Letter says specific deviations were: * failing to ensure that, for each batch of API, appropriate laboratory
Drugs
FDA has issued a Warning Letter to Curaleaf (Wakefield, MA) for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases. “As we examine potential regulatory pathways for the lawful
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Postmarketing Safety Reporting for Combination Products Guidance for Industry and FDA Staff.” The document describes and explains a 2016 final rule on postmarketing safety reporting (PMSR) for combination products. It provides recommendations for complying with the PMSR requirements as
Devices
Medtronic has submitted a PMA for non-adjunctive labeling for its Guardian Sensor 3, which is part of the MiniMed 670G insulin delivery system. If the agency approves a sensor with non-adjunctive labeling, it means that a sensor is accurate enough to be used to calculate an insulin dose
Drugs
Restore Public Trust, a self-described non-partisan public interest group, says lobbying spending disclosures for the first half of 2019 show that the drug industry is doubling down to leverage its influence over policymakers. Restore Public Trust director Lizzy Price says that “HHS secretary Alex Azar and President Trump
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. High Chemical Co., Waretown, NJ (7/2): FDA inspected the firm in February and found significant GMP deviations with active pharmaceutical ingredients (API). For example, the firm failed to
Drugs
Bayer says it is recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials in the U.S. to the patient level. A company statement posted by FDA says that certain vials from the two lots that were labeled as Kogenate FS actually contain the FVIII hemophilia A
Biologics
FDA has approved a Pfizer BLA for Ruxience (rituximab-pvvr), a biosimilar to Biogen’s Rituxan for the treatment of adult patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangiitis and microscopic polyangiitis. Approval was based on the review of a comprehensive data package, which demonstrated
Drugs
FDA has approved nine ANDAs for first generics of Pfizer’s Lyrica (pregabalin) for managing neuropathic pain associated with diabetic peripheral neuropathy, and for managing postherpetic neuralgia. The generics are also indicated as adjunctive therapy for treating partial onset seizures in patients 17 years of age and older, for managing
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a proposed information collection for “Generic Clearance for Quick Turnaround Testing of Communication Effectiveness.” The collection is intended to allow FDA to use quick turnaround surveys, focus groups, and in-depth interviews collected from consumers and other stakeholders to communicate FDA issues
FDA Policy/General
Federal Register notice: FDA is publishing a list of information collections that have been approved by OMB. They are: * Experimental Study of an Accelerated Approval Disclosure * Interstate Shellfish Dealer’s Certificate * Administrative Detention and Banned Medical Devices * Medical Device User Fee Small Business Qualifications and Certifications * Individual Patient Expanded Access
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Bar Code Label Requirement for Human Drug and Biological Products” (OMB Control Number 0910-0537). The agency requires bar codes on most human prescription drug products and on over-the-counter drug products that are dispensed under
Drugs
FDA has issued Biohaven Pharmaceutical Holding Co. a complete response letter on a 505(b)2 application seeking approval for Nurtec (riluzole) for treating amyotrophic lateral sclerosis (ALS). The letter raised concerns with the use of an active pharmaceutical ingredient (API) that was manufactured by Apotex Pharmachem India Private Ltd.
Devices
Becton Dickinson has recalled its Alaris Pump Module Model 8100 bezel assembly because of a defect that could result in free flow, over-infusion, under-infusion, or interruption of infusion. A recall notice says that the bezel posts may become cracked and separated which could lead to inaccurate fluid delivery
Drugs
Vanda Pharmaceuticals says it has received FDA notification about undisclosed deficiencies that “preclude discussion of labeling and postmarketing requirements/commitments” involving a supplemental NDA for Hetlioz (tasimelteon) for treating jet lag disorder. FDA stated that the notification does not reflect a final decision on the information under review. The user
Drugs
A new study in BMJ criticizes the strength of the data on which FDA based its 2017 approval of an Otsuka Pharmaceutical NDA for mental disorder-treating Abilify MyCite (aripiprazole tablets with sensor) — the first drug-device combination in the U.S. with a digital ingestion tracking system. Study researchers