FDA Policy/General
Former FDA deputy commissioner Scott Gottlieb, who served under George W. Bush, has been nominated by president Donald Trump for the FDA commissioner post. Drug company executives had earlier signaled their preference for Gottlieb, who is a physician and fellow at the American Enterprise Institute. In response to the nomination,
Drugs
FDA has granted eFFECTOR Therapeutics an orphan drug designation for lead product candidate eFT508 and its use for treating diffuse large B-cell lymphoma, an aggressive form of non-Hodgkin lymphoma. eFT508 is described by the company as a potent, highly selective inhibitor of MNK1 and MNK2, two enzymes that
Drugs
FDA has denied a Purdue Pharma petition asking it to to ensure that applications for approval of follow-on products citing Purdue’s Butrans (buprenorphine) transdermal system as the reference-listed drug are supported by pharmacokinetic data establishing equivalent buprenorphine exposure over the entire seven-day dosing interval. “Absent such
Drugs
FDA has extended by three months its review of a Radius Health NDA for abaloparatide-SC , indicated for treating postmenopausal women with osteoporosis, to allow additional time to review an agency-requested information request that was recently submitted. The new user fee review target date us 6/30. In its
Drugs
Congresswoman Chellie Pingree (D-ME) has re-introduced the Safe and Affordable Drugs from Canada Act (HR 1480), which would allow Americans to import prescription drugs from Canadian pharmacies. Under the bill, imported prescription drugs would have to be purchased from an approved Canadian pharmacy and dispensed by a licensed
Devices
CDRH says it is expecting more collection of data on patient preference in device clinical trials. Asked a question during a recent teleconference (see transcript) on the agency’s final guidance on “Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions,” CDRH policy analyst Karen
Devices
Stryker has ended patient enrollment early in its DAWN clinical study comparing mechanical thrombectomy with the Trevo Retriever plus medical therapy against medical therapy alone. An independent data safety monitoring board recommended stopping enrollment based on a pre-planned interim review of data from the first 200 patients, “which concluded
Drugs
Regeneca Worldwide, a division of VivaCeuticals, is recalling its entire line of herbal and dietary supplement products under a consent decree entered by the Central District of California federal court. The recall applies to all products manufactured and sold between 6/2011 and 2/8/2017. Products affected include RegeneSlim,
Drugs
Attorneys Neil O’Flaherty and Jur Strobos (Baker McKenzie) say that FDA has responded to congressional instructions by increasing its inspection focus on foreign drug production sites’ current good manufacturing practices (CGMP) and using its new tool of “refusing inspections” to shut down or impose import alerts on foreign drug
Drugs
Nicox has resubmitted an NDA for AC-170 (cetirizine), an eye drop formulation for treating ocular itching associated with allergic conjunctivitis, after receiving FDA confirmation that GMP concerns surrounding the production site of the active pharmaceutical ingredient have been resolved. In 10/2016, the agency sent a complete response letter
Drugs
Par is asking FDA to modify its denial of a company 8/1/16 petition that asked the agency to take specific steps involving ANDAs for an epinephrine injection 1mg/mL product in a 1 mL vial, ampule, pre-filled syringe, or similar parenteral administration modality. Specifically, the Par petition
Drugs
After meeting 3/9 with Maryland Democrat Elijah Cummings, the White House backed off a commitment Cummings said President Trump made to help Democrats push through legislation to give the federal government power to negotiate drug prices, particularly under Medicare. Cummings had described the president as being very much onboard
Drugs
Epstein Becker Green is asking FDA to establish a reasonable review timeline for assessing appeals of letter of designation decisions from the FDA Office of Combined Products. The firm’s 3/3 petition says that letter of designation decisions may be appealed to the associate commissioner of special medical programs,
Drugs
FDA has granted Boehringer Ingelheim an orphan drug designation for its anti-CD33 monoclonal antibody BI 836858 for treating myelodysplastic syndromes (MDS). “Preclinical studies with our anti-CD33 monoclonal antibody have shown promising therapeutic potential in myelodysplastic syndromes, a rare group of bone marrow disorders,” the company says. A Phase
Drugs
The Dr. Reddy’s oncology drug formulation manufacturing facility at Duvvada, Visakhapatnam, India, that was one of the facilities named in a 2015 Warning Letter, has been issued an FDA-483 containing 13 inspection observations, according to a company statement to India financial regulators and the New York Stock Exchange.
Devices
FDA has issued a safety alert to warn of potentially contaminated SPS-1 Static Preservation Solution distributed by Organ Recovery Systems, Inc. The clear to light yellow, sterile solution is intended for the flushing and cold storage of kidney, liver, and pancreas at the time of organ removal from a
Devices
FDA has approved a Zoll Medical Corp. PMA for the Hospital Wearable Defibrillator (HWD). The device is designed to continuously protect patients at risk of ventricular tachycardia or ventricular fibrillation (VT/VF) during their stay in the hospital. “For a patient experiencing VT/VF, each minute that defibrillation is delayed
Drugs
Horsham, PA-based contract manufacturer Pharmaceutical Manufacturing Research Services (PMRS) is asking FDA to revoke all indications for use of any opioids in management of chronic pain, saying there is insufficient evidence to support such an indication. Specifically, the group is asking that the agency: * revoke approval of OxyContin’s
Devices
FDA has issued a safety communication to alert healthcare providers and others about its concerns with transvascular autonomic modulation, an experimental procedure using balloon angioplasty devices to treat autonomic dysfunction. The communication says the procedure may put patients at risk because it is being promoted as treatment for a variety
FDA Policy/General
Federal Register Notice: FDA has amended a 1/11 notice of a Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee joint meeting. The meeting address has been changed to: Tommy Douglas Conference Center, 10000 New Hampshire Ave., Silver Spring, MD 20903. To
Drugs
An analysis by the Tufts Center for the Study of Drug Development and Sakai Regulatory Consulting found multiple issues with the 505(b)(2) drug regulatory pathway, including longer approval times than for new molecular entities (NMEs) and fewer expedited review designations than NMEs. As reported in the center’s
Devices
Physio-Control Inc. has begun a Class 1 recall of its Lifepak 1000 Defibrillators due to an electrical issue that may cause the device to shut down unexpectedly. The recall covers 50,000 devices made from 6/2016 to 12/2016. The devices are used to deliver lifesaving electrical shocks