Drugs
FDA has published a draft guidance, Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations, to assist sponsors in reproductive toxicity assessments (mainly of embryo-fetal development (EFD)) for anti-cancer pharmaceuticals. It also provides recommendations for product labeling on duration of contraception following cessation of therapy to minimize potential risk
Drugs
CDER has issued a Manual of Policies and Procedures (MAPP), Communicating Certain Deficiencies Identified During Filing Review of ANDAs, outlining policies and procedures for how the Office of Generic Drugs’ Division of Filing Review (DFR) will communicate with applicants about ANDAs that contain minor technical deficiencies and/or deficiencies that
Drugs
FDA has launched a new search tool to improve access to data on drug and biologic adverse events through its Adverse Event Reporting System (FAERS). The tool is designed to make it easier for consumers, providers, and researchers to access this information. “The new dashboard enables users to search for
Drugs
FDA commissioner Scott Gottlieb says the agency will be taking additional steps in the coming months to help more drug compounders register as outsourcing facilities. In a statement, he said the actions will include continuing to streamline the process and to appropriately calibrate the regulatory burden of operating as an
Drugs
FDA has released the FDA-483 issued following an 8/28-9/1 inspection at the Aurobindo Pharma drug manufacturing plant in Hyderabad, Telangana, India. The two specific observations cited were: * failing to have written procedures for production and process controls designed to assure that the drug products have the
Drugs
FDA has granted Cascadian Therapeutics an orphan drug designation to tucatinib for treating HER2-positive (HER2+) metastatic colorectal cancer. Tucatinib is an investigational oral, small molecule kinase inhibitor that the company says is highly selective for HER2. Cascadian is currently sponsoring an investigator-initiated Phase 2 study (MOUNTAINEER) evaluating tucatinib
Drugs
FDA has cleared a Fotona 510(k) for its new StarWalker MaQX Q-Switched laser system for treating tattoos, pigmented and vascular lesions, acne and scar revision and permanent hair reduction. The device is designed in an ergonomic compact size and features 110v or 220v and an intuitive, interactive touch
Drugs
A Health Affairs blog post looks at the differences between drug efficacy, as demonstrated in randomized clinical trials, and effectiveness, as seen in real-world evidence, and the steps that can be taken to close the gap between the two. The post notes that while in some situations the efficacy-
Drugs
FDA has issued Allergan a refuse-to-file letter on a supplemental NDA for Vraylar (cariprazine) for treating negative symptoms associated with schizophrenia in adult patients. The oral, once daily atypical antipsychotic is currently approved in the U.S. for treating schizophrenia and the acute treatment of adult patients with
Drugs
FDA has released the FDA-483 issued following a 9/11-9/15 inspection at the Dr. Reddy’s drug manufacturing facility in Mirfield, West Yorkshire, UK. The specific observations cited were: * procedures are not established or followed; * cleaning procedures or clean status is not established; and * manually managed materials
Drugs
CDER has issued a Manual of Policies and Procedures, Procedures for Completing and Processing the Form “Annual Status Report Review Form: PMR and PMC Summary,” describing procedures used by Office of New Drugs (OND) staff to (1) verify an applicant’s reported status and explanation of status for postmarketing requirements
Drugs
A 5/8-5/10 FDA inspection at Shandong Vianor Biotech, Shandong, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 9/12 Warning Letter. Specific violations cited were: * failing to ensure that laboratory records included complete data derived from all tests
Drugs
FDA medical reviewers say that the studies submitted by PTC Therapeutics supporting its NDA for Translarna (ataluren) to treat dystrophinopathies [most notably Duchenne muscular dystrophy (DMD)] resulting from nonsense mutations in the dystrophin gene (nmDMD) do not persuasively demonstrate the drug’s effectiveness. The agency’s Peripheral and Central Nervous
Drugs
FDA believes the hurricane destruction to Puerto Rico and medical product makers could be worse than first predicted. In an 9/25 update, FDA commissioner Scott Gottlieb says the agency is “very concerned” about the potential for drug shortages on and off the island. “During and following the storm, we
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Public Citizen says there is no justification for FDA not seeking public input before issuing a final guidance on “IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects.” In its comments, the advocacy group says FDA reported it had determined
Drugs
FDA has denied a US WorldMeds 7/21/15 petition asking that the agency require specific conditions for any application for a drug-device combination product containing apomorphine, intended for use in the advanced Parkinson’s disease population. Specifically, the petition asked that FDA: * require applicants to demonstrate that their
Drugs
FDA has accepted for review an Eisai supplemental NDA for Lenvima (lenvatinib) for use in first-line treatment of patients with hepatocellular carcinoma (liver cancer). The submission is based on data from the pivotal Phase 3 REFLECT trial. In the study, lenvatinib reportedly demonstrated a treatment effect on overall survival
Drugs
FDA and the HHS Office for Human Research Protections have issued a guidance on “Minutes of Institutional Review Board (IRB) Meetings.” The document is intended to harmonize the agencies’ regulatory requirements and guidance for human subject research. It outlines how to prepare and maintain minutes of IRB meetings that meet
Drugs
FDA has made available a guidance on “Expedited Programs for Serious Conditions — Drugs and Biologics.” The document outlines the four FDA programs — fast track designation, breakthrough therapy designation, accelerated approval and priority review designation — intended to facilitate and expedite development and review of new drugs to address unmet medical needs.
Drugs
FDA is deploying additional staff to Puerto Rico to work with pharmaceutical and device companies to prevent shortages of medically necessary drugs and devices, as well as assist with public health needs after Hurricane Maria decimated the island. “There are many challenges ahead, but much of the hurricane response over
Drugs
Guide on Index of Unapproved New Animal Drugs Federal Register notice: FDA makes available a draft guidance #210 entitled “The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.” 09/22/2017 PMA Summaries Available for CBER-approved Products Federal Register notice: FDA makes available the safety and
Drugs
Researchers from the Dartmouth Institute for Health Policy and Clinical Practice believe FDA should be doing more to ensure pharmaceutical sponsors meet post-approval study deadlines. With many approval candidates lagging on safety and effectiveness when drugs are first approved, the agency requires post-approval (Phase 4) studies to further