Drugs
Some 21 medical organizations and professional societies led by the American Medical Association are expressing concern that actions taken by FDA in finalizing compounding-related guidance documents “may significantly hinder our physicians’ ability to provide critical treatments to patients in office settings.” The 8/13 letter says an updated 9/
FDA Policy/General
Federal Register notice: FDA has determined that Sunovion Pharmaceuticals’ Zonegran (zonisamide) capsules, 50mg, were not withdrawn for safety or effectiveness reasons. The determination means that FDA will continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements. The drug is indicated
Drugs
President Donald Trump has told the Department of Veterans Affairs to purchase “a lot” of Johnson & Johnson’s Spravato (esketamine) to help fight veteran suicides. Trump told reporters about the purchase 8/21 as he prepared to go to a national veterans conference in Kentucky. The McClatchy news service
FDA Policy/General
The HHS Office of Inspector General (OIG) says FDA failed to submit an OIG clearance document for any of the 166 audit recommendations during FY 2016 and 2016. As a result, an OIG report says, all 166 were outstanding and listed on the stewardship report as past due for resolution
Drugs
After two decades of actual use of mifepristone to end early unwanted pregnancies, additional research, and a comprehensive review by the National Academies of Science, Engineering, and Medicines, there may no longer be a need for the distribution restrictions that were imposed when the drug was first approved in 2000.
Drugs
Regeneron is commenting on an FDA draft guidance on drug development endpoints for treating heart failure “to assist the agency in enhancing the clarity of the recommendations provided to industry and key stakeholders. We believe these clarifications will strengthen guidance on the appropriate endpoints to include in heart failure clinical
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,