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Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field. In October, FDA announced seven new clinical trial grants awarded in fiscal year (FY) 2024 – including one for a Phase 3 trial – totaling $17.2
Bile acids are crucial signalling molecules that aid the regulation of the immune system and have essential metabolic functions, like controlling lipid and glucose metabolism. The team debuted a novel tool to instantly match microbes to the metabolites they produce earlier in 2024. 2023 February 5 [2024 March 11]; 15(1).
FTC, deep in its foray into the Orange Book, filed an Amicus Brief in the case arguing that the patents do not claim any FDA-approved drug. On June 10, 2024, the District Court of New Jersey issued its Opinion in the case, finding that Teva’s patents were improperly listed.
ENTRESTO was approved by FDA in July 2015 “to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.”
3558 ) on January 25, 2024. The Act is intended to address national security concerns by prohibiting certain conduct by regulated industry. In this regard we note that Medicaid is described in federal regulations as “Federal grants to States for medical assistance.” House of Representatives ( H.B. 7085 ) and Senate ( S.B.
The American Conference Institute (“ACI”) will be hosting the go-to forum for critical updates on OTC regulation and enforcement, monograph reform, ACNU and advertising essentials… and FDA Law Blog readers can get a discount. Deb along with fellow panelists Kyle Y.
The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.
A Wave of Innovations The year 2024 has already proven to be significant for the field of biologics, witnessing a notable increase in FDAapprovals. In the first quarter alone, the FDAapproved 9 new biologics, a substantial rise from the 5 approvals during the same period in 2023.
In 1940, Charles Drew—the first African-American researcher to earn a doctor of medical science degree at Columbia University—developed an ingenious method for separating and storing plasma , the liquid part of blood that contains essential proteins that promote clotting and regulate blood pressure. ” Asimov Press (2024).
As with other FDA-regulated products, such as human drugs and medical devices, the “regulatory review period” is composed of a “testing phase” and a “review phase.” The “review phase” is the period between the initial submission and approval of the NADA. FDA’s PTE regulations at 21 C.F.R.
Since the PTE statute was created with the September 1984 enactment of the Hatch-Waxman Amendments, and even post-AIA, there have been various instances in which FDA-regulated companies (or their counsel) have failed to timely submit a PTE application to the PTO within the statutory 60-day window ( see, e.g. , here ). Patent Nos.
Rescheduling Recommendation, 2024FDA’s 2023 analysis and recommendation finally came to light when Texas attorney Matt Zorn posted it on his website a week ago. FDA, Basis for the Recommendation to Reschedule Marijuana Into Schedule III of the Controlled Substances Act, 3. chemotherapy-induced), and pain.
In January 2024, the U.S. The ramifications of the Federal Claims case and some of the other lawsuits brought by Vanda could be significant to regulated industry and to the food and drug bar. Court of Federal Claims allowed Vanda’s Fifth Amendment takings claim to move forward in litigation. VANDA PHARMACEUTICALS, INC.
156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. Two PTE applications were submitted to FDA ( See FDA Docket Nos. Patent Nos.
Gaulkin — In May 2023, we posted about a CMS proposed regulation that sought to make a wide variety of changes to the Medicaid Drug Rebate Program (MDRP), including a new “price verification survey,” and a controversial proposal to require “stacking” of discounts to different customers when determining best price. pricing, among other things.
BY ALEXANDER GAFFNEY, MS, RAC | MAY 15, 2024 10:19 PM CDT The House Energy and Commerce Committee’s Subcommittee on Health will meet on Thursday, May 16 to mark up 23 pieces of legislation. 7384: The Creating Hope Reauthorization Act of 2024 This bill is relatively brief and simple. DORIS MATSUI (D-Calif.) and GUS BILIRAKIS (R-Fla.),
BY AMANDA CONTI | JUL 24, 2024 9:57 PM CDT Background: Modernizing regulation of over-the-counter (OTC) products Nonprescription products, also called over-the-counter (OTC) products, must demonstrate the ability to be used safely and effectively without the supervision of a qualified healthcare professional.
In fact, federal law and regulation appear to require AbbVie to list these patents.” No matter how Congress and FTC frame it, it is FDA that’s to blame for the listing confusion when it has had more than 20 years to respond to questions about whether these types of patents should have been listable in the first place.
1 In 2017, the US Food and Drug Administration (FDA) approved the first AAV-based gene replacement therapy (Luxturna), for Leber congenital amaurosis type 2. 2 Since then, the FDA has approved four more AAV-based gene therapies—Zolgensma, Hemgenix, Elevidys and Rocktavian—for treating various diseases. Labcompare.
While fees payable for OTC Monograph Order Request (OMOR) submissions have previously been published in March, six months after the start of the fiscal year, the fees are now being published prior to the start of the 2024 fiscal year. Without sufficient resources, the FDA is unable to do so. Read AgencyIQ analysis here.]
This year we completed investigational new drug (IND) enabling studies of ONC-841, which is an antagonist of Siglec-10, and received US Food and Drug Administration (FDA) approval for first-in-human study (FIH) in patients with solid tumours. 2022 May 1 [cited 2024 Oct 10];22(5):611–21. The Lancet Infectious Diseases [Internet].
Interneuron migration is regulated by L-type calcium channels (LTCCs), encoded by the CACNA1C gene. Recently, a network-based drug-screening platform has been developed to test FDA-approved drugs for Alzheimer’s disease (AD) using 1,300 iPSC-derived organoids from 11 sporadic AD patients. 16(4):443 (2024). Pharmaceutics.
156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDAapproval. In a February 16, 2024 response to the PTO’s ORDER TO SHOW CAUSE, “Applicant submits that the PTE statute (35 U.S.C. §
The delayed enforcement is part of FDA’s finalized guidance, “Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing.” . | Cosmetics must also be in compliance with the Fair Packaging and Labeling Act ( FP&L Act ); however, only color additives require FDAapproval before they may be used in cosmetics.
Broad-spectrum antiviral drugs often have trouble finding pre-existing markets because regulators and consumers favor drugs that treat specific diseases, rather than drugs that have broad applicability. As a result, it is classified as a “drug-free” product and does not require FDAapproval. Cite: Brian Wang.
In a new final rule, FDA carves out a regulatory niche for medical gases Industry has been lobbying FDA and Congress to regulate medical gases different from other types of drug products since the 1970s. Following this process, FDASIA directed the FDA to submit a report to Congress summarizing its findings.
But despite a recent attempt by the FDA to wrangle the industry into some degree of control, the agency has not followed through on a threat to go after companies that failed to go through a required premarket review process. According to the FDA’s estimates, this status applies to approximately 3,400 products. [
What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.
What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. This is what OIRA is currently reviewing.
In response to this hysteria, regulation was aggressively tightened. In 2012, an Israeli company called Protalix gained approval for their plant-based enzyme product for Gaucher’s disease. Kanuma, their FDA-approved protein product for rare lysosomal diseases, is “purified from the egg white of transgenic hens.”
This proposed rule has been in the works for over 20 years, during which time the regulation of drug compounding has gone through many changes. BY CHELSEY MCINTYRE, PHARMD | MAR 20, 2024 10:32 PM CDT Background: Drug compounding in the U.S. Now, the proposed list is out, and its limited length may be a surprise to stakeholders.
AdComm votes in favor of new colorectal cancer screening test, but questions about serial testing and labeling remain In May 2024, the FDA’s Molecular and Clinical Genetics Device panel voted 7-2 in favor of the approval of a new blood-based screening test for colorectal cancer, which would be the first blood-based test of this type.
BY AMANDA CONTI, CHELSEY MCINTYRE, PHARMD | JAN 3, 2024 5:44 PM CST Background: Benzene impurities The U.S. One impurity of concern to regulators is benzene, which the Q3C guideline classifies as a Class 1 impurity, or a solvent that should be avoided due to its carcinogenic and environmental hazard properties.
BY RACHEL COE, MSC | APR 24, 2024 10:56 PM CDT Biosimilars and interchangeable products The FDA was first authorized to develop a pathway for the approval of biosimilar products in 2010 under the Biologics Price Competition and Innovation (BPCI) Act. Comments on the revised draft are requested by June 25, 2024.
Though regulations guide some aspects of how expiration dates are determined, the agency has but limited power to extend those dates unilaterally. BY CHELSEY MCINTYRE, PHARMD | JAN 24, 2024 4:09 PM CST Back to the beginning: What does an expiration date mean to the FDA?
For more than a century, scientists thought of gas vesicles as little more than a natural curiosity and, later, as a way for microbes to regulate buoyancy. At least six types of CAR-T cells have already passed through clinical trials and garnered FDAapproval. ” Asimov Press (2024). Cite this essay: Niko McCarty.
Unpacking FDA’s long-awaited platform technology designation program and guidance Months overdue, the FDA’s Platform Technologies Designation guidance document has just been published by the agency. The first requirement is straightforward: the approach in question must have been used by a product that has already gained FDAapproval.
Over the course of the PHE—which spanned more than three years—the FDA used its expanded authority extensively to issue new direct-to-final guidance documents, creating over 80 in total. The FDA also implemented new flexibilities for certain regulated products and processes, typically via enforcement discretion.
Food and Drug Administration (FDA) approved the update of the Imbruvica Prescribing Information to include efficacy and safety data for the combination of Imbruvica with rituximab for the treatment of Waldenström’s macroglobulinemia (WM). and by AbbVie outside of the U.S. AbbVie announced that the U.S.
On Thursday, May 16, 2024 , the Attorney General issued a Notice of Proposed Rulemaking (“NPRM”) to initiate rulemaking proceedings to reschedule marijuana. The NPRM was signed by the Attorney General but published by DEA in the Federal Register on May 21, 2024. 44,597 (May 21, 2024). 802(16)) and regulated by 21 C.F.R.
BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The FDA will follow these procedures for both agency-initiated operations (e.g.,
But in a major decision today, the Supreme Court unanimously ruled that The Alliance for Hippocratic Medicine and the doctors it represented had not demonstrated adequate proof of standing to sue the FDA, offering the agency significant relief from the prospect of endless litigation. They were not purchasing mifepristone.
What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.
Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Lorbrena, expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).
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