Drugs
A 5/15-5/19 FDA inspection at Guangdong Zhanjiang Jimin Pharmaceutical Co., Zhanjiang City, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 10/30 Warning Letter. The letter says the firm also manufactures and distributes a product for over-the-
Drugs
The 6th Circuit Court of Appeals has upheld on a 2-1 vote a lower federal court’s dismissal of a whistleblower suit against Bristol-Myers Squibb that was based on allegations of off-label promotion. Attorney Andrew Hull (Hyman, Phelps & McNamara) writes in his firm’s FDA Law
Drugs
FDA has published a guidance on “Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention” that discusses the overall development program and clinical trial designs for drug products with an antiviral mechanism of action used to prevent or treat the condition. The guidance does not address drug products used to
Drugs
Sen. Kamela Harris (D-CA) says she has launched an investigation into the drug maker Alkermes and its efforts to artificially boost sales of Vivitrol, a treatment for opioid addiction. In a statement, Harris referenced news reports indicating that the company attempted to boost sales of its own product while
Drugs
FDA has denied a 6/9 petition submitted by Millennial Pharmaceuticals asking that FDA: * not approve any ANDA or 505(b)(2) bortezomib product for any multiple myeloma indication with labeling that omits information on the safe and effective conditions of use for the treatment of relapsed patients; * not approve
Drugs
FDA scientists working in the agency’s Oncology Center of Excellence (OCE) describe the Center’s role in the 5/2017 approval of a cancer treatment based on a biomarker without regard to the tumor’s site. The Experimental Biology and Medicine article describes the accelerated approval given to pembrolizumab
Drugs
FDA has lifted its 9/4 clinical hold on Cellectis’ UCART 123 product candidate Phase 1 trials in acute myeloid leukemia and blastic plasmacytoid dendritic cell neoplasm. The company says it agreed with FDA on a number of revisions to be implemented in the Phase 1 trial protocols. “Cellectis is
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Biomin Industries Tempe, AZ (10/13): FDA inspected the dietary supplement firm and cited its product labeling for unapproved new drug violations. The claims on the labels establish that
Drugs
FDA has posted a guidance on “Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery.” The document applies to single-ingredient aspirin, buffered aspirin, and aspirin in combination with an antacid, labeled with cardiovascular-related imagery marketed under the agency’s Tentative Final Monograph
Drugs
FDA has released a guidance on “Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment.” The document covers the development of such products, including clinical trial designs, from the pre-IND through the NDA and postmarketing stages. The agency defines direct-acting hepatitis C virus (HCV) antivirals
Drugs
Legislative language in an FY 2018 Defense Department spending bill would give the military the authority to approve the emergency use of medical products, outside the U.S., in situations in which an emergency use of an unapproved product or an emergency unapproved use of an approved product cannot be
Drugs
In a move that may signal the agency’s increasing reliance on real world data, FDA has reversed its decision to require TherapeuticsMD to submit additional endometrial safety information to address the only approvability issue raised in a May-issued complete response letter (CRL) on an NDA for TX-004HR,
Drugs
FDA has posted a revised draft guidance on “ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence).” It describes the process for generic drug applicants to pre-submit complete, accurate facility information in advance of a priority ANDA, prior approval supplement, or amendment
Drugs
FDA has concluded that healthcare provider continuing education can be a useful method for providing continuing education (CE) under a risk evaluation and mitigation strategy (REMS). A new report, “REMS and Continuing Education for Health Care Providers — FDA Feasibility Report,” finds that it is generally not practical to incorporate CE
Drugs
Trevena has submitted an NDA for Olinvo (oliceridine injection) for treating pain. Olinvo, the sponsor says, was designed to improve conventional opioid pharmacology to deliver the pain-reducing potential of an opioid but with fewer associated adverse effects due to its biased ligand mechanism of action. The G protein-biased
Drugs
FDA has posted a final guidance on “Formal Dispute Resolution: Sponsor Appeals Above the Division Level” that provides recommendations for industry and review staff for resolving scientific and medical disputes between CDER or CBER and sponsors that cannot be resolved at the division level. A few examples of regulatory actions
Drugs
FDA has issued a draft guidance, Controlled Correspondence Related to Generic Drug Development, with information on the process by which generic drug manufacturers and related industry or their representatives can submit to FDA controlled correspondence requesting information related to generic drug development. The document also describes the agency’s process
Drugs
FDA commissioner Scott Gottlieb says the agency is talking with drug companies about possible changes to opioid packaging to reduce access to the drugs. He told CNN that companies might find the agency’s action “disruptive” and “uncomfortable.” In addition to packaging changes, he said FDA could promote ways to
Drugs
FDA Webview has posted the court-approved consent decree between FDA and Philips North America that prohibits manufacturing, processing, packing, holding, or distributing medical devices made by the firm’s Emergency Care and Resuscitation business unit at facilities in Andover, MA, and Bothell, WA, until they comply with agency regulations
Drugs
FDA has accepted a Bayer BLA for BAY94-9027, an extended half-life PEGylated recombinant human Factor VIII compound for treating hemophilia A in adults and adolescents 12 years of age and older. The submission is based on data from the PROTECT VIII pivotal Phase 2-3 trial that was
Drugs
FDA has approved a Bausch + Lomb and Nicox NDA for Vyzulta (latanoprostene bunod ophthalmic solution, 0.024%), indicated for reducing intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The once daily therapy has a dual mechanism of action, according to the company, and works by metabolizing into
Drugs
FDA has denied a 2/26/16 Empire State Consumer Project (ESCP) petition asking that it test all brands of OTC and prescription drug products containing polyethylene glycol 3350 (PEG 3350) for the presence of selenium, determine the source of any selenium found in the tested products, and issue a