Drugs
FDA says that benefit-risk assessment is a fundamental element of the agency’s drug regulatory decision-making, and both the agency and stakeholders continue to see value in FDA’s Benefit-Risk Framework (BRF) as a tool to support internal agency decision making, improve communication to internal and external
FDA Policy/General
FDA says growth in its user fee programs in terms of scope of activities and the volume and complexity of submissions has increased operational demands on the agency. “To help ensure that the agency is making optimal use of its financial resources to maximize its ability to efficiently and effectively
Drugs
FDA has released the FDA-483 containing 11 observations issued following a 2/12-3/5 inspection at SCA Pharmaceuticals, Windsor, CT. Specific observations were: * the written stability program for drug products does not include reliable and meaningful test methods; * procedures designed to prevent microbiological contamination of drug products purporting
Drugs
University of Pittsburgh researchers say that cancer drugs are approved faster in the U.S. than in overseas countries. The study was reported in the Journal of Managed Care & Specialty Pharmacy. The researchers looked at 45 oncology drugs approved by FDA between 2009 and 2013. They found that most
Drugs
The Justice Department says Gao Mei Fang (also known as Amy Gao), of Shanghai, China, pleaded guilty to mail fraud and smuggling charges in connection with a scheme to sell mislabeled dietary supplements. An agency news statement says Gao was the supply chain manager for Genabolix USA and Shanghai Yongyi
Devices
An Arizona federal jury has awarded a plaintiff $3.6 million in a bellwether case involving C.R. Bard’s inferior vena cava (IVC) filter. District Court judge David Campbell limited plaintiff Sherr-Una Booker’s claims to defective design, failure to warn, and punitive damages. Booker had the device
Drugs
FDA has granted Proteostasis Therapeutics a fast track designation for its triple combination product for cystic fibrosis, consisting of cystic fibrosis transmembrane conductance regulator (CFTR) modulators known as PTI-428, PTI-801 and PTI-808. All three drug candidates were discovered internally at the company and are “designed to act
FDA Policy/General
Federal Register Final Rule: FDA has amended the animal drug regulations to reflect application-related actions for NADAs and ANADAs during October, November, and December 2017. The agency is making available summaries of their basis for approval. The regulations are also being amended to reflect sponsorship changes to applications and
Drugs
FDA has accepted for priority review a Pfizer NDA for dacomitinib, a pan-human epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer with EGFR-activating mutations. The European Medicines Agency has also accepted an
Devices
FDA has cleared an Aesku Group 510(k) for its Aeskuslides nDNA (Crithidia luciliae) assay and its use on the company’s new Helios Automated IFA System. The kit is the second clearance for its immunofluorescence assay on the Helios, after its ANA HEp-2 cleared in 2016. Immunofluorescence assays
FDA Policy/General
Federal Register Final Rule; technical amendment: FDA has amended certain medical device regulations to correct editorial issues, such as typographical errors, and to ensure accuracy and clarity in the regulations. The changes also update addresses, office titles, and wording to ensure accuracy. To view the notice, click here.
Drugs
Endo says it has agreed to extend a temporary stay of its litigation against FDA seeking a court declaration that the agency’s interim policy on compounding using bulk drug substances under Section 503B of the Drug Quality and Security Act of 2013 (DQSA) is contrary to law because it
Devices
At the 3/30 meeting of the FDA Clinical Chemistry and Clinical Toxicology Devices Advisory Panel, members indicated that the benefits of using glucose meters for measuring blood glucose in capillary blood in patients receiving intensive medical intervention/therapy outweigh the risks. The comment came in response to FDA’s
Drugs
FDA has released the establishment inspection report from its 5/22-6/2/17 inspection at the Celltrion Yeonsgu-go Plant 1, Inchon City, Korea. The report says the inspection found that the firm continues to manufacture a drug substance, Inflectra (infliximab-dyyb), for the U.S. market as well
Devices
FDA has approved a W. L. Gore expanded indication for its Gore Cardioform Septal Occluder for patent foramen ovale (PFO) closure to prevent recurrent ischemic strokes. The device was previously approved for closure of atrial septal defects up to 17 mm. The expanded was supported by data from the REDUCE
Drugs
FDA has ordered a mandatory recall of all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmaceuticals. An agency media statement says the recall was ordered after several products were found to contain salmonella and the company failed to cooperate with an FDA request for a
Drugs
Several drug companies are asking the Supreme Court to resolve differences between Circuit Courts of Appeals on the question of whether consumers who think they might have paid less for treatment if a drug product were packaged differently is sufficient to establish an economic injury that can be subject of
FDA Policy/General
Federal Register notice: FDA has withdrawn approval of five NDAs because the drug products are no longer marketed and the sponsors requested the action. To view the notice, click here.
Drugs
Several stakeholder groups have submitted comments thanking FDA for its three public meetings on implementation of the Drug Supply Chain and Security Act (DSCSA) and suggesting improvements to the program. The American Society of Healthsystem Pharmacists asked the agency to consider its recommendations on stakeholder engagement, hospital- and health system-
Drugs
FDA has approved an AstraZeneca NDA for Bydureon (exenatide extended-release) for injectable suspension as an add-on therapy to basal insulin in adults with Type 2 diabetes with inadequate glycemic control. The expanded use is based on data from the 28-week DURATION-7 study, which examined the effect
FDA Policy/General
Industria Farmacéutica Andrómaco (Toluca, Mexico) has recalled topical drug product Pasta De Lassar Andromaco zinc oxide diaper rash treatment after an FDA laboratory analysis confirmed its contamination with high levels of yeast, mold, and bacteria. “This is especially concerning because Pasta De Lassar Adromoca is labeled for use to relieve
Devices
AdvaMedDx says it appreciates what FDA has done to review and clarify its policies on study designs that can support both 510(k) and CLIA waiver applications. In comments, it notes that it also commented on a related docket on select updates for recommendations for CLIA waiver applications for manufacturers