Drugs
An FDA 9/11-9/19/23 inspection at the Bell International Laboratories drug manufacturing facility in Eagan, MN, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 2/15 Warning Letter says specific violations were: * failing to establish an adequate quality unit and to
Drugs
A 9/18-9/21/2023 FDA inspection at the Colgin, Inc., drug manufacturing facility in Dallas, TX, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 1/25 Warning Letter says specific violations were: * failing to conduct at least one test to
Drugs
FDA has published a guidance, Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes, to help manufacturers and distributors of a new dietary ingredient to submit required premarket safety notifications, known as New Dietary Ingredient Notifications (NDIN). The document focuses on frequently asked questions about the NDIN submission and review
Drugs
The Parenteral Drug Association (PDA) says an FDA “Draft Report and Plan on Best Practices for Guidance” does not provide an overview and metrics on the initiatives in an agency 2011 good guidance practices report. PDA says it suggests that FDA include a section in the draft report with the
Drugs
Sen. Tim Scott (R-SC) and Rep. Earl Carter (R-GA) say they are concerned that a recent FDA draft guidance on advanced manufacturing technologies does not meet Congress’ intent expressed in provisions of their Manufacturing API, Drugs, and Excipients (MADE) in America Act. The guidance implements provisions in the
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Federal Register notice: FDA is amending its standing advisory committee regulations to add the 12/13/2023 establishment of the Genetic Metabolic Diseases Advisory Committee. The new committee is intended to review and evaluate data on the safety and effectiveness of marketed and investigational human drug and biologic products for
Drugs
Novo Nordisk says it will file a supplemental NDA this year seeking an expanded label for Ozempic (semaglutide) for preventing progression of kidney impairment and risk of kidney and cardiovascular mortality in people with Type 2 diabetes and chronic kidney disease (CKD). The submission will be based on data from
Drugs
FDA has approved Sandoz’ Jubbonti (denosumab-bbdz) injection as an interchangeable biosimilar to Amgen’s Prolia (denosumab) and Sandoz’ Wyost (denosumab-bbdz) injection as an interchangeable biosimilar to Amgen’s Xgeva (denosumab). An agency statement says Jubbonti is approved for the same treatment indications as Prolia, while Wyost is approved
Drugs
FDA has extended by three months its review of a Zevra Therapeutics NDA resubmission for arimoclomol, an investigational oral treatment for Niemann-Pick disease Type C (NPC). The new user fee review action target date is 9/21, according to the agency, which also re-affirmed its intent to present
Drugs
FDA has lifted a partial clinical hold on Iovance Biotherapeutics’ IOV-LUN-202 trial investigating the company’s LN-145 TIL cell therapy in non-small cell lung cancer (NSCLC). “In collaboration with the FDA and an independent data monitoring committee, Iovance developed additional safety measures and monitoring,” the company
Drugs
SpringWorks Therapeutics has begun a rolling NDA for mirdametinib, an investigational MEK inhibitor for treating pediatric and adult patients with neurofibromatosis Type 1-associated plexiform neurofibromas (NF1-PN). The rare genetic disorder is caused by mutations in the NF1 gene. “The clinical course of NF1 is heterogeneous and manifests in
Drugs
Endo Health Solutions has agreed to plead guilty in federal court and pay over $2 billion in penalties to resolve criminal and civil investigations related to the company’s sales and marketing of the opioid drug Opana ER with INTAC, according to a Justice Department release. “The criminal resolution includes
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FDA has refused to grant a hearing request by Vanda Pharmaceuticals on a stalled supplemental NDA for Hetlioz (tasimelteon) capsules, 20 milligrams (mg) for treating jet lag disorder. “Based on a review of the parties’ submissions, FDA finds that there is no genuine and substantial issue of fact justifying a
Drugs
FDA has approved an Allecra Therapeutics NDA for Exblifep (cefepime/enmetazobactam) for treating complicated urinary tract infections (cUTIs), including pyelonephritis, in patients 18 years and older. For obtaining approval, the agency granted to company a five-year marketing exclusivity extension under the Generating Antibiotic Incentives Now Act. The approval was
Drugs
FDA has released a draft guidance on “Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards.” The document provides recommendations on provisions in HHS’ regulations on protecting human subjects in clinical trials and it addresses the presentation of key information and includes recommendations
Drugs
FDA has granted full approval to Johnson & Johnson’s Rybrevant (amivantamab-vmjw) in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by
Drugs
FDA has published a guidance, Clinical Pharmacology Considerations for Antibody-Drug Conjugates, with recommendations to assist industry and other parties involved in the development of antibody-drug conjugates (ADC) with a cytotoxic small-molecule drug or payload. The document addresses the agency’s current thinking about clinical pharmacology considerations and
Drugs
In a wide-ranging interview with the NTD global television network, FDA commissioner Robert Califf said that it is very difficult for states to meet the criteria established by Congress to permit bulk drug importation from Canada. Asked whether he expected importation to gain traction now that the agency has
Drugs
Former pharmacy compounder Patient Care America (PCA) CEO and president Patrick Smith (Palm Beach Gardens, FL) was sentenced to six months in prison for lying to federal agents who were investigating PCA for various health care fraud offenses. The FDA Office of Criminal Investigations case investigated PCA over health care
Drugs
The Association for Accessible Medicines raises these concerns about an FDA draft guidance on quality considerations for topical ophthalmic drug products: * identification and qualification thresholds; * validation of analytical methods for extractables; and * acceptance criteria for leachables. Alcon updates its comments, questions, requests for clarification, and general comments in a table
Drugs
FDA commissioner Robert Califf says he is very concerned about the prevalence of compounded and fake versions of the new weight-loss drugs such as Novo Nordisk’s Wegovy (semaglutide) and Lilly’s Zepbound and Mounjaro (tirzepatide). In a Reuters interview, he says that consumers seeking the branded medications are
Drugs
A RAND study funded by HHS finds that nearly 85% of new drugs sold in the U.S. were sold here either first or in the same quarter in which they were introduced in other Organization for Economic Cooperation and Development countries. The study analyzed data on prescription drug availability