Drugs
FDA says it has awarded new 19 new grants and two new contracts worth more than $38 million in funding over the next four years to support clinical trials, natural history studies, and regulatory science tools related to rare diseases. An agency statement says funding is from the Orphan Products
Drugs
FDA and academic researchers say the results of a cross-sectional study suggest that a lack of adequate representation of older adults in clinical trials for new drug evaluation can present challenges for optimal use and prescribing. The study results were published in the open-access JAMA Network Open. The
Drugs
The Association for Accessible Medicines (AAM) says FDA should change the 2018 ANDA Amendments guidance and its Appendix A to conform to changes included in the recent GDUFA 3 commitment letter. “In reevaluating each item in Appendix A,” the association says in a comment letter, “we encourage FDA to consider
Drugs
With the recent user fee reauthorization having abandoned sought-after FDA reforms when time ran out for Congress to act, commissioner Robert Califf has revived his previous support for revamping the drug accelerated approval program. Delivering remarks 10/17 at the 2022 National Organization for Rare Disorders (NORD) Breakthrough Summit
Drugs
A 4/11-4/15 FDA inspection at Beijing Xinggu Lvsan Technology Co. (formerly Bejing Lvsan Technology Co.), Beijing, China, found significant violations of current good manufacturing practice (CGMP) regulations and other violations in the firm’s manufacturing of finished drugs. A 10/5 Warning Letter says specific violations were:
Drugs
FDA has released a draft guidance entitled “Tissue Agnostic Drug Development in Oncology.” The document provides recommendations to sponsors on considerations for tissue agnostic drug development. The guidance says a “tissue agnostic” oncology drug “targets a specific molecular alteration (a kind of biomarker) across multiple cancer types as defined, for
Drugs
FDA has issued a draft guidance entitled “Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials.” The document is intended for sponsors of products that modulate the endogenous immune system and may disrupt immunologic tolerance to normal organs and tissues. These include monoclonal antibodies, anticancer vaccines,
Drugs
FDA has made available a final guidance entitled “Acute Myeloid Leukemia (AML): Developing Drugs and Biological Products for Treatment.” The document provides the agency’s current thinking on the overall development program and clinical trial designs for drugs to support an indication for treating AML, including indications limited to an
Drugs
FDA has extended by three months its review of an NDA for Biogen’s tofersen, an investigational new drug intended to treat superoxide dismutase 1 amyotrophic lateral sclerosis, known as Lou Gehrig’s Disease. The revised user fee review action target date is 4/25/2023. During the submission’s
Drugs
FDA says it has revised the following two compliance programs on inspections that are being implemented, effective 10/17: * CP 7346.832—Preapproval Inspections — the program guidance provides procedures involving NDAs and ANDAs; and * CP 7356.002—Drug Manufacturing Inspections — the program guidance provides procedures for GMP surveillance inspections at
Drugs
FDA has released a final guidance entitled “ANDA Submissions – Prior Approval Supplements (PAS) Under GDUFA.” The document explains how the recently reauthorized generic drug user fee program relates to PAS submissions. It also incorporates performance goals currently outlined in the reauthorization. Specifically, the guidance describes how the user fee performance
Drugs
Travere Therapeutics is expecting FDA to extend by three months its review of an accelerated approval-seeking NDA for sparsentan and its use in treating IgA nephropathy. “As part of its late-cycle review, the FDA has requested that the company update its proposed Risk Evaluation Mitigation Strategy (REMS) to
Drugs
Revive Therapeutics says it has finalized an amended protocol for the company’s Phase 3 clinical trial designed to evaluate the safety and efficacy of bucillamine, an oral drug with anti-inflammatory and antiviral properties for treating patients with mild to moderate Covid-19. The amended protocol includes a new
Drugs
Exela Pharma Sciences (Lenoir, NC) has recalled 49 lots of sodium bicarbonate injection, 8.4%, 50 mEq/50 mL vials, due to safety concerns about vial breakage and flying glass when pressurized while preparing the product for administration. Exela has received five reports of flying glass injuring skin, eye and
Drugs
FDA is seeking public comments on a “Statement of Work” mandated by the recent drug user fee reauthorization to assess communication between the agency and sponsors through product quality information requests (IR) during NDA/BLA reviews, and to identify best practices and areas of improvement. The independent assessment will also
Drugs
A Miami grand jury has charged three defendants for their roles in an alleged scheme to fabricate and falsify clinical drug trial data submitted to FDA, according to a Department of Justice release. The just-unsealed indictment has charged Miguel Montalvo, Bernardo Garmendia, and Ivette Portela, all of Miami, with
Drugs
FDA has published the International Council for Harmonization (ICH) E19 Guideline, A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials, that was endorsed by the regulatory members of the ICH Assembly on 9/27. The document says selective safety data collection
Drugs
FDA has released a CDER letter sent to the presiding officer for an upcoming hearing on whether the approval for Covis’ Makena should be withdrawn, asking that Covis be directed to provide additional information. The letter asks for additional information on four tables included in the Covis submission and on
Drugs
FDA says there is a shortage of the immediate-release formulation of amphetamine mixed salts, known primarily as Adderall or Adderall IR. The agency drug shortage Web site says one of the manufacturers of amphetamine mixed salts, Teva, is experiencing ongoing intermittent manufacturing delays. While other manufacturers continue to produce
Drugs
FDA has published a final guidance, Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA, to assist applicants and holders of approved NDAs, ANDAs, and BLAs with implementing a chemistry, manufacturing, and controls (CMC) postapproval change by using a comparability protocol
Drugs
FDA is soliciting input on a discussion paper, Distributed Manufacturing and Point-of-Care Manufacturing of Drugs, that presents areas the agency has identified for consideration as it evaluates the existing risk-based regulatory framework as it applies to those technologies. In a statement, FDA says the discussion paper “considers
Drugs
The CBER Office of Compliance and Biologics Quality says its review of a Web site maintained by Regener-Eyes, Palm Harbor, FL, established that the firm markets an “acellular biological product” that is composed of “placental-derived biomaterials” labeled as Regener-Eyes Ophthalmic Solution to mitigate or treat dry eye