FDA Policy/General
Federal Register notice: FDA has granted a 10/17-19 hearing request to review and vote on whether agency approval for Covis’ Makena (hydroxyprogesterone caproate injection) should be withdrawn. In 2011, FDA approved the NDA under the accelerated approval pathway for reducing the risk of preterm birth in women with
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 30 NDAs from multiple applicants after they notified the agency that the products are no longer marketed. To view the notice, click here.
Devices
FDA has published a final rule establishing a new regulatory category of over-the-counter (OTC) hearing aids so that consumers with perceived mild to moderate hearing impairment may purchase hearing aids directly from stores or online retailers without a medical examination, prescription, or fitting adjustment by an audiologist. An
Devices
FDA has published a guidance, Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices, updating a 2003 updated guidance. The latest document says the 2003 guidance described a mechanism for manufacturers to follow when applying an assay that was previously cleared based on performance characteristics when used with
Drugs
A 9/27-10/15/21 FDA inspection at the Verde Cosmetic Labs drug manufacturing facility in Northridge, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 3/30 Warning Letter says specific violations were: * failure of the firm’s quality control
Drugs
An HHS Office of Inspector General (OIG) audit says the National Institutes of Health (NIH) failed to ensure that all clinical trial results were reported to ClinicalTrials.gov under federal requirements. The OIG audit found that most NIH-funded clinical trials that were completed in 2018 did not have their
Drugs
CDER deputy director for regulatory programs Douglas Throckmorton told the GMP by the Sea conference that domestic drug inspections of facilities have been at “standard operational levels” since 10/2021 and foreign inspections have been performed for six months, except in China. Attorney Douglas Farquhar (Hyman, Phelps & McNamara) reports
Drugs
FDA has released the Warning Letter issued following a 2/7-2/18 inspection of the drug manufacturing facility at Cangene BioPharma, doing business as Emergent BioSolutions, Baltimore, MD (see previous story) The 8/10 Warning Letter says specific violations were: * failing to clean, maintain, and, as appropriate for the
Drugs
FDA has published a technical specifications document, FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products, to assist submitters in transmitting electronic individual case safety reports and attachments to the FDA Adverse Event Reporting System (FAERS) database. The document describes
Drugs
FDA has accepted for review a Roche supplemental BLA for Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) for treating people with previously untreated diffuse large B-cell lymphoma (DLBCL). The agency set a user fee review action target date of 4/
Drugs
FDA has accepted for priority review an AstraZeneca supplemental NDA for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for treating adult patients with metastatic castration-resistant prostate cancer (mCRPC). The submission is based on data from the PROpel Phase 3 trial that showed Lynparza in combination with
FDA Policy/General
Federal Register notice: FDA has established a docket to solicit comments on the content of Appendix A in the 7/2018 guidance for industry entitled “ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA.” The opportunity for comments fulfills an agency commitment under the generic drug user fee agreement.
Drugs
While the recently passed Inflation Reduction Act authorizes Medicare to negotiate the prices of 10 high-cost drugs in 2026 and 10 more in 2029, a new analysis finds that drugs launched so far this year have a median annual cost of $257,000 — a 43% increase above the annual
Drugs
FDA has issued Emergent BioSolutions an 8/10 Warning Letter citing the firm’s Camden, MD manufacturing facility based on a February inspection. The 87,000-sq. ft. contract manufacturing facility in Baltimore provides drug product manufacturing for sterile injectables, according to the company. It offers clinical and commercial non-
Drugs
Alain Bouaziz, a French national and Hexim Pharmaceuticals chief executive officer, has pleaded guilty to making false statements to FDA to gain control of the rights to sell a weight-loss drug in the U.S. Beginning in 2018, The U.S. Justice Department says Bouaziz submitted forged documents and
Biologics
Gilead Sciences has filed a supplemental BLA for Trodelvy (sacituzumab govitecan-hziy) in patients with HR+/HER2-metastatic breast cancer who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy. The submission includes just-announced “statistically significant and clinically meaningful results from the second interim
Devices
Medtronic has recalled (Class 1) its Cobalt and Crome implantable cardioverter defibrillators because the devices have the potential for reduced shock energy (about 79% of programmed energy) during high-voltage therapy. The company says it has issued a software release to update the Cobalt and Crome implantable cardioverter defibrillators and
Devices
FDA has cleared a Dyad Medical 510(k) for its echocardiogram application called Echo:Prio. The device is part of the company’s Libby cardiac platform, which is intended to provide fast, data-driven image analysis of echocardiogram images. The cloud-based, artificial intelligence-powered platform also provides users an
Biologics
Novartis says two children died of acute liver failure weeks after being administered Zolgensma (onasemnogene abeparvovec-xioi), a gene therapy indicated for treating patients under age 2 with spinal muscular atrophy. The therapy currently carries a Boxed Warning for acute liver failure. The deaths were first reported by Stat. “While
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Agreement for Shipment of Devices for Sterilization — 21 CFR 801.150” (OMB Control Number 0910–0131). The collection supports the agency’s control mechanism that allows firms to manufacture and label medical devices as sterile at one
FDA Policy/General
Federal Register notice: FDA is publishing the following nine guidances released by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products: (1) Draft guidance for industry entitled “Effectiveness of Anthelmintics: Specific Recommendations for Canines (Revision 1).” To view this notice, click here. (2) Draft guidance
Drugs
FDA has approved a Roche a supplemental NDA for Xofluza (baloxavir marboxil) for treating acute uncomplicated influenza in children aged five to less than 12 years of age who have been symptomatic for no more than 48 hours. Additionally, the agency approved Xofluza for preventing (post-exposure prophylaxis) influenza in