Drugs
FDA is planning to release in the coming months a draft guidance on “Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making.” Speaking during an online 9/16 Alliance for a Stronger FDA program, CDER associate director for strategic initiatives Theresa Mullin said this was the last in a
Drugs
An 8/23-9/3/21 FDA inspection at BioLab Sciences, Scottsdale, AZ, found the company manufactures products derived from human amniotic fluid for allogenic use and an epidermal skin tissue product for autologous use. An 8/23 Warning Letter says BioLab has distributed the products to third-party distributors,
Drugs
FDA medical reviewers have raised significant questions in advance of a 9/22 meeting of the agency’s Oncologic Drugs Advisory Committee to consider Spectrum Pharmaceuticals’ application for accelerated approval of Pozenveo (poziotinib) to treat patients with previously treated locally advanced or metastatic non-small cell lung cancer harboring human
Drugs
FDA reviewers say that a confirmatory trial has not confirmed the clinical benefit of Oncopeptides’ Pepaxto (melphalan flufenamide), which could jeopardize the continued marketing of the 2021 accelerated-approved drug for use in treating certain patients with relapsed or refractory multiple myeloma (RRMM). The agency’s Oncologic Drug Advisory Committee
Drugs
The Alliance for Regenerative Medicine (ARM) says it appreciates the FDA targeted draft guidance on real-time oncology review (RTOR). The ARM comment letter makes suggestions in terms of eligibility and application of RTOR at CBER and for cell and gene therapy, alignment with the Oncology Center of Excellence RTOR
Drugs
FDA and the other regulatory agencies that are members of the Generic Drug Cluster have spent their inaugural year in meetings in which they collaborated on several regulatory topics. In an online CDER Conversation, Office of Generic Drugs (OGD) associate director for global generic drug affairs Sarah Ibrahim says many
Drugs
Companies that market drugs for off-label uses need not only worry about running afoul of FDA but also shareholders who learn about such practices and decide to sue when such public information causes their stock to lose value. An Eastern New York federal judge has preliminarily approved an $11.
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A federal jury has convicted former Unlimited Medical Research clinical researcher Jessica Palacio (Miami, FL) for making a false statement to a government investigator related to her role in a clinical trial that studied the effectiveness of asthma drugs in children. The FDA Office of Criminal Investigations case began after
Drugs
FDA has approved a Heron Therapeutics NDA for Aponvie (aprepitant) injectable emulsion, indicated for preventing postoperative nausea and vomiting in adults. The drug is intended to be administered via a single 30-second intravenous injection, and maintains therapeutic plasma concentrations for at least 48 hours, the company says. Approval was
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HHS has outlined specific FDA projects that will be undertaken as part of President Biden’s recent Executive Order launching a National Biotechnology and Biomanufacturing Initiative (NBBI). According to the department, NBBI will “help drive research and development, improve access to quality federal data, grow domestic manufacturing capacity, expand market
Drugs
The Justice Department says Akorn Operating Company, an Illinois pharmaceutical company, has agreed to pay $7.9 million to resolve a whistleblower’s allegations that it caused Medicare to pay false claims by delaying its request to FDA to switch drugs from prescription to over-the-counter. A department statement
Drugs
FDA has granted in part and denied in part a Catalyst Pharmaceuticals 7/8/21 petition asking the agency not to consider any NDA to use amifampridine to treat congenital myasthenic syndromes (CMS) approvable based on a mechanistic argument of efficacy and to require the NDA to include well-controlled,
Drugs
Novartis is petitioning FDA to take specified actions on any ANDAs citing its heart failure drug Entresto (sacubitril and valsartan) oral tablets as the reference-listed drug. The 9/12 petition asks that FDA: * refrain from approving any ANDA referencing Entresto during the three-year exclusivity period covering labeling changes
Drugs
FDA has published an International Conference for Harmonization guidance, Q3D(R2) Elemental Impurities, on controlling within acceptable limits elemental impurities in drug products. The document contains three parts: * the evaluation of the toxicity data for potential elemental impurities; * the establishment of a permitted daily exposure (PDE) for each element of
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FDA investigators are paying close attention to pharmaceutical water systems during inspections and the agency has cited water deficiencies in about 17% (10) out of more than 60 Warning Letters issued this year, according to CDER Office of Manufacturing Quality director Francis Godwin. Speaking at the FDA/PDA Regulatory conference
Drugs
FDA has approved Mallinckrodt’s Terlivaz (terlipressin) injection for improving kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function. The agency says Terlivaz is the first approved medication for this condition. HRS is most common in those with advanced cirrhosis and ascites, fluid buildup in
Drugs
In an amicus brief filed with the 2nd Circuit Court of Appeals, the Washington Legal Foundation (WLF) says the court should affirm a New York federal court’s dismissal of a suit brought by six women against Forest Laboratories over its antidepressant drug Lexapro (escitalopram). In their suit, the women
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Vanda Pharmaceuticals has filed a lawsuit in the DC District Court against FDA seeking an order to compel it to publish in the Federal Register a notice of opportunity for a hearing related to a complete response letter (CRL) on a supplemental NDA for Hetlioz (tasimelteon) for treating jet lag
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FDA has released the form FDA-483 issued following a 7/25-8/2 inspection at the Aurobindo Pharma active pharmaceutical ingredient manufacturing facility in Andhra Pradesh, India. The observations were: * procedures for the cleaning and maintenance of equipment are deficient regarding the removal or obliteration of the previous batch
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FDA says it is joining the National Institutes of Health in launching the Critical Path for Rare Neurodegenerative Diseases, a public-private partnership to advance the understanding of neurodegenerative diseases and foster the development of treatments for amyotrophic lateral sclerosis and other such diseases. An announcement says the two agencies
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CDER director Patrizia Cavazzoni has removed Bob Temple’s deputy Center director title and renamed him senior advisor for clinical science within her immediate office. Temple’s previous deputy position no longer exists in Cavazzoni’s current office structure. Asked whether the new title represents a significant change in his
Drugs
CDER has issued a Manual of Policies and Procedures (MAPP) on how it determines whether a current CDER special government employee (SGE) can represent a sponsor before FDA about a specific application. The MAPP says CDER SGEs may, under some circumstances, legally represent sponsors in meetings with FDA. “Although such