WEBFeb 22, 2021 · The US Active Pharmaceutical Ingredient Infrastructure: The current state and considerations to increase US Healthcare Security “Keeping the Nation’s drug supply chain secure, robust, and resilient is essential for the national security and economic prosperity of the United States1.” I. Summary
Generic Version of Sanofi-Aventis’ Multaq Gets Tentative Approval
WEBJan 12, 2022 · Alembic Pharmaceuticals has gotten tentative approval for its abbreviated new drug application (ANDA) for dronedarone, a generic equivalent to Sanofi-Aventis’ anti-arrhythmic Multaq, which the FDA approved in 2009. Dronedarone is indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of …
FDA Clarifies Guidance on Submitting Field Alert Reports
WEBAug 2, 2021 · The FDA added some clarifications in a final guidance for sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) on submitting field alert reports (FARs), reminding them that FAR requirements apply to all products under an NDA or ANDA including positron emission tomography drugs, designated medical …
Good Documentation: More Than Entering Data | 2014-08-13
WEBAug 13, 2014 · Good Documentation Practices are guided by five standards. These standards consist of truth, accuracy, completeness, legibility, and timeliness. Truth: This standard maintains that the person who completed the process or performed the task actually did the work—and completed the appropriate documentation. No signature …
Three New Keytruda Indications Among Mid-October Approvals
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WEBSep 16, 2019 · FDA publishes these product-specific guidances to foster drug product development, and ANDA submission and approval, ultimately providing increased access to safe, affordable generic drugs. These guidances are published in an incremental manner and listed below in alphabetical order according to the active ingredient's name.
Novartis’ Pluvicto Gets FDA Approval for Advanced Prostate
WEBMar 25, 2022 · The FDA has approved Novartis’ Pluvicto for the treatment of an advanced form of prostate cancer in patients who have previously received chemotherapy. Pluvicto (lutetium Lu 177 vipivotide tetraxetan) is a radioligand therapy that combines a targeting compound with a therapeutic radioisotope. The approved indication is for the treatment …
FDA Expands Clearance for Two NuVasive Cervical Spine Products
WEBFebruary 28, 2023. The FDA has cleared an expanded indication of a combination of NuVasive’s Modulus Cervical interbody implant with Attrax Putty bone void filler. Attrax Putty is the first synthetic bone graft substitute to receive FDA clearance for use in thoracolumbar interbody fusion spacers. The devices are part of the company’s C360 ...
WEBAug 6, 2009 · 10 Common Mistakes/“Tips” for Responding to the Warning Letter. Know your Audience The Response is your First Impression Understanding the Observation/Violation Establish a Comprehensive Corrective Action Plan. • Following Through on CAP. Address the Specific Observation Identify Root Cause Solutions (Systems) Consider …
FDA Sheds More Light on Infectious Disease Drug Designations
WEBMay 13, 2021 · The FDA has finalized guidance on qualified infectious disease product (QIDP) designations, drug designations that are meant to encourage the development of certain antibacterial and antifungal products for serious or life-threatening infections. The final guidance provides a revised 14-item Q&A section on what products are eligible for …