Drugs
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Badrivishal Chemicals & Pharmaceuticals Maharashtra, India (3/2): FDA inspected the firm 8/2016 and cited significant GMP deviations for manufactured active pharmaceutical ingredients (API). For example, FDA investigators
Devices
FDA has approved a Medtronic PMA for its Melody Transcatheter Pulmonary Valve (TPV) and its implanted use in patients whose surgical bioprosthetic pulmonary heart valves have failed. The device is designed specifically for the pulmonic position. “Intended to prolong the time between open-heart surgeries for patients with a dysfunctional
FDA Policy/General
Federal Register notice: FDA has announced a list of 1,003 Class 2 devices that the agency is proposing to exempt or partially exempt from premarket notification [510(k)] requirements. FDA believes that the devices identified are sufficiently well understood and do not present risks that require premarket notification review
Drugs
FDA has notified Sun Pharma that it will lift the import alert imposed on its Mohali (Punjab) drug manufacturing facility in India, clearing the path for the company to supply approved products from the facility to the U.S. market under standard FDA regulatory requirements. Sun says it inherited the
Drugs
An 8/16-8/19/16 FDA inspection at Badrivishal Chemicals & Pharmaceuticals, Maharashtra, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients, according to a 3/2 Warning Letter. Specific deviations cited in the letter included: * failure to validate and monitor the water
Drugs
A 9/26-9/28/16 FDA inspection at Lumis Global Pharmaceuticals, Wuhan, China, found significant deviations from current good manufacturing practices (CGMP) for active pharmaceutical ingredients (API), according to a 3/2 Warning Letter. Specific deviations cited in the letter include: * failure to transfer all quality or regulatory information
Drugs
Hogan Lovells attorneys say that 2016 was a year of expansion for the False Claims Act (FCA). The firm’s first annual review of the act and its whistleblower provisions says there were “very significant changes to the way courts apply the FCA.” It references in particular a 6/16/
Devices
FDA says that the Medtronic 9/2016 recall of its SynchroMed implantable infusion pumps due to a software problem that may cause unintended delivery of drugs during a priming bolus procedure is Class 1. An agency notice says the SynchroMed II and SynchroMed EL implantable infusion pumps are programmed to
FDA Policy/General
Federal Register notice: FDA has established a public docket to accept comments on its ongoing efforts to enhance mechanisms for patient engagement at the agency, including establishing a new Office of Patient Affairs. The new office would be “tasked with supporting and coordinating patient engagement activities across medical product centers
FDA Policy/General
Federal Register Notice: FDA has announced a 4/5 joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss an Inspirion Delivery Sciences NDA for oxycodone hydrochloride immediate-release oral tablets, indicated for management of moderate
Drugs
In order to speed drug products through the development process, more resources are needed for FDA to advance activities such as the Critical Path Initiative and the use of new methods for clinical trials (e.g., adaptive trial designs and Bayesian statistical methodologies), according to former FDA commissioner Andrew von
Drugs
FDA has published a guidance on “Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims” that is intended to help applicants in developing labeling for cardiovascular outcome claims for hypertension drugs. “With few exceptions, current labeling for antihypertensive drugs includes only the information that these drugs are indicated to reduce blood
FDA Policy/General
Federal Register Notice: FDA has announced a regional public meeting entitled “U.S. Food and Drug Administration and Health Canada Joint Regional Consultation on International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).” The meeting is intended to provide information and receive comments on the current
FDA Policy/General
[Editorial by Jim Dickinson] For the first time in our 35-year history as the oldest FDA-centered news publisher, Dickinson’s FDA Webview is endorsing a candidate for FDA commissioner: Scott Gottlieb. His nomination, announced by President Trump 3/9, quickly drew predictable alarums about Gottlieb’s “deep ties”
FDA Policy/General
FDA is seeking comments on its ongoing efforts to enhance mechanisms for patient engagement at the agency, including establishing a new Office of Patient Affairs. The agency says this concept was suggested in earlier public feedback received under patient engagement meetings mandated under the FDA Safety and Innovation Act. An
Drugs
FDA has placed a partial clinical hold on Karyopharm Therapeutics clinical trials for selinexor (KPT-330) due to incomplete information contained in an existing version of the investigator brochure (IB). While the hold remains in effect, patients with stable disease or better may remain on selinexor therapy, the company says,
Drugs
Sunovion Pharmaceuticals has submitted a supplemental NDA to expand the indication for its antiepileptic drug Aptiom (eslicarbazepine acetate) to include use as monotherapy or adjunctive therapy treating partial-onset seizures in children four years of age and older. The drug is currently approved for this indication in adults. Sunovion is
Drugs
Researchers from a number of institutions, led by former FDA principal deputy commissioner Josh Sharfstein, have developed a new “Blueprint for Transparency at FDA.” Sharfstein, now associate dean at Johns Hopkins Bloomberg School of Public Health, led FDA efforts to increase transparency during the early days of the Obama Administration.
Drugs
FDA has approved Novartis’s Kisqali (ribociclib) in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer. Kisqali is a CDK4/6 inhibitor, and it was
Devices
FDA has cleared a Medtronic 510(k) for its Reveal LINQ Insertable Cardiac Monitor (ICM) with TruRhythm Detection, an advanced cardiac monitor offering designed to identify abnormal heartbeats. The device offers “exclusive algorithms that result in a 95% reduction in false bradycardia (slow heartbeat) episodes and a 47% reduction in
FDA Policy/General
OncBioMune Pharmaceuticals has acquired Vitel Laboratorios, which gives OncBioMune two drugs sold in Mexico — Bekunis for constipation and Cirkused for stress. Vitel has a total of seven other products that are either already in the registration stage or planned for launch later in 2017. Mylan has agreed to the terms
FDA Policy/General
Drug Safety/Anesthetic and Analgesic Meeting Address Change Federal Register Notice: FDA amends a 1/11 notice of a Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee joint meeting. 03/08/2017 Flonase Not Withdrawn Due to Safety/Effectiveness Federal Register Notice: