Drugs
An Avoca Group white paper defines and describes a risk-based approach to clinical trial inspection readiness, based on activities related to risk-based quality management (RBQM). The paper says RBQM is a “systematic process put in place to identify, assess, control, communicate, and review the risks associated with the
Drugs
FDA has released an updated version of the Clinical Outcome Assessment (COA) Compendium “to encourage development and implementation of patient-focused clinical outcome assessments in clinical trials to support drug approvals and labeling claims. The agency says the compendium is a communication tool that organizes and summarizes COA information for
Drugs
Selectively sharing information with stock analysts and not through open public disclosures after meeting with FDA on a product development issue is a “no-no.” So learns TherapeuticsMD, a pharmaceutical company headquartered in Boca Raton, FL, after being charged by the Securities and Exchange Commission (SEC) 8/20. According to
FDA Policy/General
Federal Register notice: FDA has announced a 9/26 joint Pediatric Advisory Committee and Drug Safety and Risk Management Advisory Committee meeting. Panel members are scheduled to discuss the pediatric-focused safety review for OxyContin (oxycodone hydrochloride) extended-release tablets. They will also discuss pediatric data considerations for opioid analgesics
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Prescription Drug Product Labeling; Medication Guide Requirements” (OMB Control Number 0910–0393). To view the notice, click here.
Devices
National Center for Health Research president Diana Zuckerman says an FDA decision to allow some medical device manufacturers to submit summary reports of adverse events through a hidden Alternate Summary Reporting database was “very inappropriate and unfair to patients and physicians.” As reported online by Cancer Therapy Advisor, Zuckerman said
Drugs
CBER director Peter Marks tells Stat News he issued a public statement addressing Novartis’ data manipulation in the application for its Zolgensma to be sure the episode did not set back development of other gene therapies. Any case in which data are mishandled and patients are harmed could set the
Drugs
FDA has granted Astellas Pharma and Pfizer a priority review for their supplemental NDA for Xtandi (enzalutamide) that is seeking an indication for treating men with metastatic hormone-sensitive prostate cancer (mHSPC). The drug is currently indicated for treating patients with castration-resistant prostate cancer. The submission is based on
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Patent Term Restoration; Due Diligence Petitions; Filing, Format, and Content of Petitions 21 CFR part 60” (OMB Control Number 0910-0233). The collection supports agency regulations under the authority of the Drug Price Competition and Patent Term
Devices
BioElectronics has filed a 510(k) that seeks expanded clearance for its ActiPatch Musculoskeletal Pain Therapy, a drug free, over-the-counter device seeking an indication for “adjunctive treatment of musculoskeletal complaints pain.” The device is already FDA-cleared for over-the-counter treatment of pain from knee osteoarthritis and
Drugs
Endo International and Allergan have agreed to pay $15 million to resolve litigation brought by two Ohio counties accusing several drug companies and distributors of fueling the U.S. opioid epidemic. Reuters reports Endo will pay $10 million to the counties and provide up to $1 million worth of two
Drugs
Sen. Gary Peters (D-MI), ranking member on the Senate Homeland Security and Governmental Affairs Committee, is asking FDA acting commissioner Ned Sharpless for information about ongoing drug shortages and current and planned agency actions to address the situation. In an 8/21 letter, Peters says the number of active
Devices
A 1/28-2/15 FDA inspection at Polymer Technology Systems, Indianapolis, IN, found Quality System Regulation and other violations in the firm’s manufacturing of in vitro medical devices designed for point-of-care diagnosis and management of diabetes, heart disease, kidney function, and other chronic diseases. A 7/
Drugs
A 12/17/18-2/15/19 FDA inspection at TG United, Brooksville, FL, found current good manufacturing practice (CGMP) violations in the firm’s production of finished pharmaceuticals. An 8/1 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of a batch
FDA Policy/General
Federal Register notice: FDA has announced a 10/16 Antimicrobial Drugs Advisory Committee meeting. Panel members are scheduled to review a Shionogi NDA for cefiderocol lyophilized powder for intravenous administration, indicated for treating complicated urinary tract infections, including pyelonephritis due to gram-negative bacteria in patients with limited or no
Drugs
FDA is pointing to a new Warning Letter to a Chinese drug manufacturer as evidence of its increased “oversight of over-the-counter drug manufacturing and protecting consumers from products that may put them at risk.” The Warning Letter to Ningbo Huize Commodity cited GMP violations, including data integrity issues,
FDA Policy/General
Federal Register notice: FDA has announced a 10/30 Bone, Reproductive and Urologic Drugs Advisory Committee meeting. Panel members are scheduled to review an Agile Therapeutics NDA for levonorgestrel and ethinyl estradiol transdermal system, indicated for preventing pregnancy. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a pilot program to test the processing and analysis of nonclinical study data provided electronically for the Clinical Data Interchange Standards Consortium for its Standard for Exchange of Nonclinical Data (SEND) Implementation Guide: Version 3.1 (SEND 3.1). CDER is inviting individual firms
Drugs
Federal Register notice: FDA has corrected a 6/8/2011 notice about the approval withdrawal of 70 NDAs and 97 ANDAs from multiple applicants. That notice contained the incorrect applicant information for NDA 018380, which has now been corrected to reflect that it belonged to Hospira. To view the notice,
FDA Policy/General
Federal Register notice: FDA has announced a 9/18 public workshop entitled “Implementing FDA’s Predictive Toxicology Roadmap: An Update of FDA’s Activities.” The workshop will highlight the work FDA has been doing to support and implement its predictive toxicology roadmap. To view the notice, click here.
Drugs
The United States Pharmacopoeia (USP) says it is updating organic impurities testing for articles subject to USP-NF (National Formulary) standards. A USP notice says the approach applies the International Conference on Harmonization (ICH) Q3A/B-based limits for identification and reporting of organic impurities and degradation products in drug
Drugs
FDA has issued a complete response letter (CRL) to Sarepta for its NDA seeking accelerated approval of golodirsen injection for treating Duchenne muscular dystrophy in patients with a confirmed mutation amenable to exon 53 skipping. The company says the CRL generally raises two concerns: the risk of infections related to