Drugs
The Supreme Court is likely to decide at the beginning of its term in 10/2023 whether to hear Shire’s appeal from an 11th Circuit Court of Appeals decision in a case involving state failure-to-warn law and the Highlights section of a drug’s labeling. That’s
Biologics
The International Society for Pharmaceutical Engineering (ISPE) says FDA should incorporate the concepts and terms in the International Council for Harmonization Q12 guidance on technical and regulatory considerations for pharmaceutical product lifecycle management in an FDA draft guidance on manufacturing changes and comparability for human cellular and gene therapy products.
Devices
FDA has cleared the Samsung Wellysis unit’s wearable electrocardiography (ECG) patch, S-Patch Ex. The ECG and heart rate recording device is designed for both at-home and clinical settings. The device uses Samsung Electronics’ next-generation bio-processor for capturing accurate ECG waveforms, according to the company.
Drugs
A 9/12 White House statement discusses steps taken by FDA to address cancer drug supply issues and prevent impacts to patients. The statement identifies these FDA actions: * for generic carboplatin and cisplatin, the agency worked closely with cancer drug manufacturers to help identify opportunities to increase manufacturing capacity and
Devices
Abbott is recalling (Class 1) its Proclaim and Infinity implantable pulse generators (IPGs) due to complaints from patients who are unable to exit MRI mode. The Patient Controller (iPhone/iPod) may lose the ability to communicate with its IPG while in MRI mode, a recall notice says. It adds that
Drugs
FDA has accepted for priority review a Madrigal Pharmaceuticals NDA for resmetirom and its use in treating adult patients with nonalcoholic steatohepatitis (NASH). The agency has set a 3/14/2024 user fee review action date. The company is seeking accelerated approval. Resmetirom is described as a once daily, oral,
Drugs
Commenting on an FDA draft guidance on determining “good cause” for noncompliance with postmarketing requirements, Pharmaceutical Research and Manufacturers of America (PhRMA) says it is concerned that the proposed standard for “good cause” is unduly inflexible. The trade association recommends that the draft be revised “to account for a totality
Drugs
Bipartisan legislation was introduced 9/13 in the Senate and House to close a patent-listing loophole that drug manufacturers use to extend their exclusivity periods. “Because of incomplete coordination between the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO), drug manufacturers are currently
Drugs
FDA’s Cardiovascular and Renal Drugs Advisory Committee 9/13 voted 9 to 3 that the benefits of Alnylam Pharmaceuticals’ patisiran (Onpattro) outweigh its risks for treating cardiomyopathy induced by transthyretin amyloidosis (ATTR). Panel members who voted favorably for the drug agreed that while the benefit was small, any safety
Drugs
FDA medical reviewers are questioning the efficacy of Alnylam Pharmaceuticals’ patisiran (Onpattro) in treating a larger pool of patients as sought in an sNDA. The filing will be considered on 9/13 by the FDA Cardiovascular and Renal Products Advisory Committee. In a briefing paper released in advance of the
Drugs
FDA has published the FY 2022 annual report on the extent to which GDUFA science and research-funded projects support the development of generic drug products, the generation of evidence needed to support efficient review and timely approval of ANDAs, and the evaluation of generic drug equivalence. The report contains
Drugs
A 3/7-3/16 FDA inspection at the Safecor Health drug manufacturing facility in Woburn, MA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 9/5 Warning Letter says specific violations were: * failing to adequately inspect the packaging and labeling facilities immediately before
Drugs
A 3/27-4/3 FDA inspection at the Similasan AG drug manufacturing facility in Jonen, Switzerland, determined that the firm is marketing several unapproved new ophthalmic drugs. A 9/11 Warning Letter identifies significant violations of current good manufacturing practice (CGMP) regulations in the production of the unapproved drugs.
Drugs
FDA has issued Warning Letters to eight companies for illegally manufacturing or marketing unapproved ophthalmic products. An agency online notice (includes links to the eight Warning Letters) says the companies’ unapproved drugs are marketed to treat conjunctivitis, cataracts, glaucoma, and other ophthalmic conditions. Some of the letters also identify CGMP
Drugs
In its response to an Oncopeptides AB written appeal challenging CDER’s proposal to withdraw Pepaxto (melphalan flufenamide) from the market, CDER says the required study to confirm the drug’s accelerated approval did not meet the prespecified primary endpoint. “The sponsor’s assertion that the primary endpoint demonstrated statistically
Devices
A report submitted by the President’s Council of Advisors on Science and Technology to President Joseph Biden on “A Transformational Effort on Patient Safety” contains two recommendations for FDA action. The report says patient safety is an urgent national public health issue, with recent data showing about one in
Drugs
A new white paper by the Duke Margolis Center for Health Policy recommends that the federal government and Congress “take urgent action to establish a new coordinating effort, the Prevent Drug Shortages Initiative, with requisite authorities and funding to lead a cross-cutting effort to improve drug supply chain reliability,
Drugs
FDA’s Nonprescription Drugs Advisory Committee 9/12 voted 16 to 0 that current scientific data do not support the effectiveness of the over-the-counter monograph dosage of orally administered phenylephrine (10mg) as a nasal decongestant. Phenylephrine is the active ingredient found in a number of common OTC cold
Devices
Mallinckrodt has recalled its One-Way Valve, 22F x 22M due to reports about the devices not opening properly, which prevents or reduces the flow of ventilated air or oxygen. The device is part of the INOmax Delivery System, which delivers nitric oxide therapy gas into the tubes between the
Drugs
A Florida federal court jury has convicted two defendants in a scheme involving the falsification and fabrication of clinical trial data. The jury on 9/5 convicted Miguel Angel Montalvo Villa and Ivette Maria Portela Martinez, both of Miami, on one count each of conspiracy to commit wire fraud and
Devices
FDA has approved a LimFlow PMA for its LimFlow System for treating patients with chronic limb-threatening ischemia (CLTI) who have no other suitable endovascular or surgical treatment options and are facing major amputation. The device allows transcatheter arterialization of deep veins (TADV) and it is designed to reestablish blood
Devices
FDA has issued its first Postmarket Device Safety-Related Communications report to Congress as mandated by the 2023 Consolidated Appropriations Act. The law requires the agency to publish annually a report on the number of postmarket device signals communications issued, the sources of data for such signals, and how such