Drugs
Vertice Pharma has petitioned FDA to revise and make more stringent bioequivalence requirements outlined in its “Draft Guidance for Sucralfate Oral Suspension.” In the petition, the company asks the agency to “remove the requirement that a generic sucralfate oral suspension formulation must be both qualitatively and quantitatively the same as
Drugs
FDA has approved Foundation Medicine’s FoundationOne CDx (F1CDx), a next generation sequencing-based in vitro diagnostic test that can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type. The sponsor says that unlike other companion diagnostics, the F1CDx is a more extensive test
Drugs
FDA has released two user fee-related implementation plans as part of the recent user fee reauthorization. The first is the “Resource Capacity Planning & Modernized Time Reporting Implementation Plan,” which outlines an approach to “develop capabilities that will help ensure that the FDA is making optimal use of its
Drugs
Sunovion Pharmaceuticals has submitted an NDA for APL-130277 (apomorphine) sublingual film, indicated for treating motor fluctuations (Off episodes) in patients with Parkinson’s disease. The NDA is supported by data from a pivotal, Phase 3 study, CTH-300, which met its primary and key secondary endpoint. In the study,
Drugs
A Government Accountability Office (GAO) review says that stakeholder organizations have mixed views about FDA monitoring of Mifeprex since its 2000 approval with an indication for the medical termination of early pregnancy. Members of Congress asked GAO to review FDA’s 2016 relabeling of Mifeprex with a revised indication and
Drugs
A New York federal judge has entered a consent decree sought by FDA against Riddhi USA, ordering the company to stop selling its products until it complies with agency dietary supplement manufacturing regulations and other conditions in the decree. An agency news release says FDA alleged that the company was
Drugs
FDA has released the FDA-483 issued following a 2/12-3/5 inspection at SCA Pharmaceuticals, Windsor, CT. Inspection observations listed on the form were: * the written stability program for drug products does not include reliable and meaningful test methods; * procedures designed to prevent microbiological contamination of drug products
Drugs
Officials from FDA and the National Institutes of Health say it is important to develop new tools that could lead to biomarkers to determine the efficacy of drugs to combat opioid addiction. Writing in Science Translational Medicine, the officials say that the opioid crisis and overdose epidemic gripping the U.
Drugs
FDA has granted Amgen accelerated approval for Blincyto (blinatumomab) and its expanded use to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD). “Because patients who have MRD are more likely to relapse, having a treatment
Drugs
Insmed has submitted an NDA for Alis (amikacin liposome inhalation suspension), indicated for treating adult patients with nontuberculous mycobacterial (NTM) lung disease caused by mycobacterium avium complex. The filing is supported by data from the company’s pivotal Phase 3 CONVERT study conducted in subjects with refractory NTM lung disease.
Drugs
An HHS Office of Inspector General (OIG) report calls on FDA provide education to ensure that drug dispensers understand their responsibilities under the Drug Supply Chain Security Act (DSCSA) to receive complete product tracing information from trading partners before taking ownership of drug products. FDA concurs with the recommendation, the
Drugs
FDA has released a report entitled The Voice of the Patient: Alopecia Areata that summarizes a 9/2017 public meeting that heard from patients and caregivers about the symptoms and health effects that matter most to alopecia patients. The report can be used by drug developers seeking to develop therapies
Drugs
Attorney Steven Boranian (Reed Smith) says plaintiffs alleging that innovator companies failed to issue a warning after receiving “newly acquired evidence” of a risk must be able to tell what the company knew and when it knew it. Writing in a Drug and Device Law blog post, Boranian reviews a
Drugs
FDA has denied a Mayne Pharma 11/22/16 petition asking that the agency require specific in vitro dissolution criteria as part of the bioequivalence demonstration for any ANDA citing Doryx MPC (doxycycline delayed-release tablets), EQ 60 mg base and EQ 120 mg base as the reference-listed drug
Drugs
FDA is calling on the United States Pharmacopeia (USP) to withdraw a proposed revision to the General Notices and Requirements relating to USP drug product monographs for biological products. In a comment letter, the agency says it is “concerned that efforts to develop biological product monographs could impede or delay
Drugs
FDA has published the annual report on information related to inspections of facilities necessary for approval of a drug or medical device required by the 2017 FDA Reauthorization Act. The report shows that: * median time between inspection request from FDA staff reviewing a drug application or report to the beginning
Drugs
Federal Register notice: FDA has submitted for OMB approval an information collection extension for “Premarket Notification for a New Dietary Ingredient — 21 CFR 190.6” (OMB Control Number 0910–0330). The information collection supports agency regulations and guidance documents that requests information upon which the manufacturer or distributor has based
Drugs
A Florida federal judge has approved a consent decree of permanent injunction sought by FDA against MyNicNaxs, Deltona, FL, and company owner Chevonne Torres and officer Michael Banner. The agency says the company distributed weight loss and sexual enhancement products, marketed as dietary supplements, directly to consumers through two Web
Drugs
Attorneys Erika Maley and Jacquelyn Fradette (Sidley Austin) say that courts and litigants should be very aware of the potential preemption and jurisdiction issues raised by state suits against opioid manufacturers alleging inadequate warnings. Writing in a Washington Legal Foundation Legal Backgrounder, the two say that state tort suits’ claims
Drugs
A 5/15-5/17/17 FDA inspection at Clover Custom Blending, Tampa, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 2/28 Warning Letter. Specific violations cited in the letter were: * failing to thoroughly investigate any unexplained discrepancy or failure
Drugs
A 5/25-5/31/17 FDA inspection at Keshava Organics, Maharashtra, India, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients. A 3/15 Warning Letter says the specific deviations were: * failing to adequately investigate out-of-specification results and to implement appropriate corrective actions;
Drugs
A recent inspection of a Cipla drug manufacturing plant in Goa, India has documented significant GMP violations. According to a just-posted Form 483 from a 1/22-25 inspection, the firm failed to thoroughly review out-of specification results and in-process test failures. The inspection also revealed that