Drugs
FDA has approved a Janssen Pharmaceuticals NDA for Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for treating depression in adults who have not responded to other antidepressant medicines (treatment-resistant depression). “Because of the risk of serious adverse outcomes resulting from sedation and dissociation caused by Spravato
Drugs
Local governments in the U.S. that use CanaRx to supply prescription drugs for covered employees are raising questions about a recent FDA Warning Letter that says the online pharmacy has delivered unapproved and misbranded drugs to its U.S. consumers. A Kaiser Health News article posted by National Public
FDA Policy/General
Federal Register notice: FDA has classified software applications for contraception into Class 2 (special controls). The action is based on a 2017 Natural Cycles Nordic AB de novo classification request for the company’s Natural Cycles. Such products are identified as a device that provides user-specific fertility information for
Drugs
Alnylam Pharmaceuticals says it will complete its NDA rolling submission for givosiran, indicated for treating acute hepatic porphyria (AHP) after reporting that the ENVISION Phase 3 study met its primary efficacy endpoint and the majority of secondary endpoints. Specifically, givosiran met the primary endpoint of reduction in the annualized rate
Drugs
In a legal filing to the Massachusetts Superior Court, Purdue Pharma cites statements from state officials to make the case that it is not solely responsible for causing the state’s opioid crisis. “To be sure, there is an opioid crisis in the Commonwealth,” the document says, “but the responsibility
Drugs
FDA has released the FDA-483 issued following a 12/3-12/14/18 inspection at Michigan Medicine, an Ann Arbor, MI, drug compounder producing sterile and non-sterile drug products. The four inspection observations were: * failing to disinfect materials or supplies before they enter the aseptic processing areas; * personnel
Drugs
A 7/9-7/19/18 FDA inspection at Actavis Laboratories FL, Davie, FL, identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 2/1 Warning Letter says specific violations were: * failing to establish adequate written procedures for production and process control designed
Devices
RVO 2.0 has recalled its Raindrop Near Vision Inlay because data from a post-approval study showed an increased risk of corneal haze (a type of cloudiness in the cornea due to inflammation) associated with the device. The device is now owned by RVO 2.0, doing business as
Drugs
The Tufts Center for the Study of Drug Development says contract research services have become an integral component of drug development, representing the single largest category of research and development spending by pharmaceutical and biotechnology companies worldwide. The Center’s latest Impact Report (subscription or purchase required) estimates 2018 expenditures
Drugs
Apotex has recalled four lots of drospirenone and ethinyl estradiol tablets because the contraceptive may contain defective blisters with incorrect tablet arrangements or an empty blister pocket. The affected product is manufactured by Oman Pharmaceutical Products Co. According to a recall notice, the packaging error could cause a patient to
Drugs
A 7/10-7/18 FDA inspection at Andapharm, Ft. Lauderdale, FL, found repeat violations of current good manufacturing practice regulations for finished pharmaceuticals. A 2/28 Warning Letter says specific violations were: * failing to establish and follow adequate written procedures for cleaning and maintaining equipment; * failing to establish and
Drugs
National and international ultrasound societies have petitioned FDA to remove a “black box” warning from ultrasound contrast agent (UCA) labels. The petition, filed by the International Contrast Ultrasound Society, cites an extensive body of favorable safety data that were not available in 2007 when the boxed warnings were first mandated
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for its “Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable” (OMB Control Number 0910-0582). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for its “Guidance on Reagents for Detection of Specific Novel Influenza A Viruses — 21 CFR Part 866” (OMB Control Number 0910-0584). To view the notice, click here.
Drugs
Pharmaceutical Research and Manufacturers of American (PhRMA) says FDA should consider publicly disclosing supporting documentation and information for surrogate endpoints used for approvals of NDAs and BLAs with all necessary protections for trade secrets and confidential information, as is the practice with qualified biomarkers, and should use the List of
Devices
AdvaMed says two FDA draft guidances on self-monitoring blood glucose test systems for over-the-counter use and prescription point-of-care use will “support accurate, reliable blood glucose monitoring test systems while also providing for innovation and continued investment in new technology.” In comment letters here (over-the-
Drugs
A bipartisan group of four senators say recent FDA guidances aimed at facilitating development of lower-cost biosimilars may have the opposite effect for development of generic insulin. In a 3/1 letter to FDA commissioner Scott Gottlieb, Sens. Richard Durbin (D-IL), Tina Smith (D-MN), Kevin Cramer (R-
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Actavis Laboratories Davie, FL (2/1): FDA inspected the firm 7/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish adequate written
FDA Policy/General
One month shy of his second full year in the job, FDA commissioner Scott Gottlieb has resigned to spend more time with his family. Gottlieb commutes from his home in Connecticut, where his wife and three young children reside. He plans to stay on at the agency through the end
Devices
FDA says it is soliciting comments on a proposal to exempt some flow cytometer instruments from 510(k) premarket notification requirements. A 3/6 Federal Register notice says the agency has determined, based on established factors, that the devices no longer require premarket notification to provide reasonable assurance of safety
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” The document addresses the agency’s policies for developing a list of bulk drug substances that can be
FDA Policy/General
Federal Register notice: FDA has identified two bulk drug substances that it has considered and is not including on its drug compounding bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need. The affected drugs are nicardipine hydrochloride and vasopressin. Additional bulk drug substances nominated by the