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
Drugs
FDA has sent Evoke Pharma a multi-disciplinary review letter on its 505(b)(2) NDA for Gimoti (metoclopramide), a nasal spray indicated for treating gastroparesis. The letter, according to Evoke, identifies three NDA sections with deficiencies and concerns. These incude: Chemistry (combination product quality control and reproducibility specific to
Drugs
Intellipharmaceutics International has resubmitted an NDA for its oxycodone ER product candidate, indicated for treating pain. In 2018, FDA issued Intellipharmaceutics a complete response letter on the NDA that provided certain recommendations and requests for information, including that it complete the relevant Category 2 and Category 3 studies to assess
Drugs
Novartis has filed a Lanham Act suit in Washington, DC federal court against Janssen seeking to stop it from making false and misleading claims associated with Janssen’s Tremfya, indicated for treating moderate to severe plaque psoriasis. Novartis manufacturers and markets a competing product, Cosentyx. The Novartis lawsuit claims that
Drugs
Former Insys Therapeutics sales vice president Alec Burlakoff testified in Boston federal court last week on how he followed orders to recruit physician and pay illegal kickbacks to increase the sales of addictive Subsys, a fentanyl-based pain drug. It is the first federal trial involving executives of an opioid
Drugs
CDER Office of Prescription Drug Promotion (OPDP) has cited Phoenix Molecular Imaging Center for promoting an investigational drug, 11C-acetate, as safe and effective on a Web page touting prostate cancer imaging. “Your Web page describes 11C-Acetate as a useful PET scan agent for detecting recurrent prostate cancer,” a
Devices
FDA has cleared an eNeura 510(k) for its single-pulse Transcranial Magnetic Stimulation (sTMS) device and expanded use in acute and preventive treatment of migraine to include children 12 years of age and older. The company received clearance for acute and preventive treatment of migraine in adults in 2017.
Biologics
FDA has agreed to accept a CytoDyn rolling BLA submission for PRO 140 (leronlimab), a CCR5 antagonist, indicated for blocking HIV-1 from entering and infecting immune cells. Previously, the agency granted a fast track designation for leronlimab as a combination therapy with highly active antiretroviral therapy for HIV-infected