Drugs
FDA says it is withdrawing its 2013 proposed rule on supplemental applications proposing labeling changes for approved drugs and biological products that would have allowed generic drug makers to independently update and distribute new safety information in drug labels. A statement from FDA commissioner Scott Gottlieb and CDER director Janet
Drugs
FDA has granted Gibson Oncology a Rare Pediatric Disease Designation for LMP-400, the company’s novel small molecule topoisomerase 1inhibitor for treating Ewing sarcoma, a rare pediatric cancer. LMP-400 has completed multiple Phase 1 human clinical trials as a single agent in advanced stage cancer patients, with the
Drugs
The Leukemia & Lymphoma Society says it supports an FDA draft guidance on regulatory considerations for use of minimal residual disease (MRD) in development of drug and biologic products to treat hematologic malignancies. “We agree with FDA’s assertion that MRD as a general measure of tumor burden has multiple
Drugs
FDA has issued a guidance, Data Integrity and Compliance with Drug CGMP Questions and Answers, to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs. The document says the term CGMP basically refers to CGMPs for drugs, including biologics. “This guidance provides the agency’s
Drugs
FDA is warning consumers that two e-liquids sold by HelloCig Electronic Technology Co. contain undeclared prescription drug active ingredients. An agency alert says that the “E-Cialis HelloCig E-liquid” contains sildenafil and tadalafil, while the “E-Rimonabant HelloCig E-liquid” contains sildenafil. FDA says the undeclared ingredients may
Drugs
Three Fried Frank attorneys say that if False Claims Act (FCA) cases that look at the materiality of the claims being made, the government should be required to provide full discovery to the parties. However, they write in a Washington Legal Foundation Legal Opinion Letter, in some recent cases, the
Drugs
TherapeuticsMD is asking FDA not to receive or approve any ANDA that references Imvexxy (estradiol vaginal inserts) unless the ANDA sponsor provides data consistent with the bioequivalence requirements suggested in the TherapeuticsMD petition. The company also asks the agency to issue a product-specific bioequivalence guidance for Imvexxy. It notes
Drugs
FDA has accepted an Intra-Cellular Therapies NDA for lumateperone, an investigational agent for treating schizophrenia. The submission is supported by data from 20 clinical trials and more than 1,900 subjects exposed to lumateperone, which received an FDA fast track designation 11/2017. The agency has set a user
Drugs
FDA has issued Mallinckrodt subsidiary SpecGx a complete response letter on its NDA for its investigational abuse-deterrent, immediate-release reformulation of Roxicodone (oxycodone hydrochloride) tablets, indicated for managing pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The company says the letter provided
Drugs
BioMarin says it commends FDA for providing recommendations for stakeholders developing human gene therapy products to treat hemophilia. The company’s comment says that overall it supports the recommendations in the agency’s draft guidance as a positive step toward providing regulatory clarity for developing these novel products. The comment
Drugs
FDA’s Office of Regulatory Affairs stepped up its Warning Letter issuance to pharmaceutical firms in fiscal year 2018 and issued 40% more letters, according to statistics (stats begin pg. 39) from FDA assistant commissioner for medical products and tobacco operations Ellen Morrison. There were 94 pharmaceutical-related Warning Letters
Drugs
FDA has cleared a DBM Corp. 510(k) for its Miracu PDO Suture Threads and its use on soft tissue approximation where absorbable sutures are appropriate. The device’s cannula (needle) has a surface coating smoother than that of traditional catgut sutures, coupled with ultra-thin walls for maximum pain
Drugs
A 7/23-8/3 FDA inspection at Zhejiang Huahai Pharmaceutical Co., Taizhou Zhejiang, China, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). An 11/29 Warning Letter said specific deviations were: * failure of the quality unit to ensure that quality-related complaints are
Drugs
FDA says Skylark CMC Pvt. Ltd., Gujarat, India, refused to cooperate with a FDA inspection beginning 6/25. A 12/3 Warning Letter says the company: * barred access to manufacturing areas; and * refused to provide copies of records sought by the inspector. The letter says FDA conducted an unannounced inspection
Drugs
FDA commissioner Scott Gottlieb says the agency is taking steps to advance the framework outlined in the July Biosimilars Action Plan by issuing four new guidances, including one that takes on companies that are “using, and sometimes abusing, limited distribution systems, sometimes in connection with Risk Evaluation and Mitigation Strategy
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Former FDA associate commissioner Peter Lurie, now president of the Center for Science in the Public Interest, and New York University journalism professor Charles Seife are suing HHS, FDA, and the National Institutes of Health in an effort to overturn their rule purporting to relieve medical researchers of their legal
Drugs
FDA has issued a draft guidance, Biomarker Qualification, Evidentiary Framework, with recommendations on general considerations to address when developing a biomarker for qualification under the 21st Century Cures Act, enacted 12/13/16. The document discusses the evidentiary framework that should be used to support biomarker qualification. FDA says the
Drugs
CDER has issued a Manual of Policies and Procedures (MAPP) to describe how the responsibility for the integrated quality assessment of products containing drug substances composed of amino acid polymers will be divided among the Office of New Drug Products, Office of Lifecycle Drug Products, Office of Process and Facilities,
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Skylark CMC Pvt. Ltd. Gujarat, India (12/3): FDA attempted to inspect the drug manufacturing facility in June but employees refused access to the manufacturing area. The firm also
Drugs
FDA has released the FDA-483 issued following a 10/22-10/26 inspection at Dishman Carbogen Amcis, a Gujarat, India, active pharmaceutical ingredient manufacturer. The two inspection observations in the document were: * blending of in-specification with out-of-specification intermediate batches is performed; and * laboratory investigations for out-
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says an FDA draft guidance on chemistry, manufacturing, and control (CMC) information for human gene therapy INDs is a positive step toward providing sponsors with more guidance and clarity, but “does not adequately adopt and identify risk-based and phase-appropriate recommendations that
Drugs
FDA has released a revised draft guidance entitled “Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act” that provides recommendations to reduce risks of contaminated or otherwise substandard products produced by outsourcing facilities. “Maintaining the necessary standards to protect