Devices
Futura Medical says it intends to pitch to FDA a medical device regulatory approval pathway for the placebo arm from the European erectile dysfunction (ED) Phase 3 study FM57 after the placebo arm outperformed the active study drug, MED2005 (nitroglycerine) gel. The placebo gel contained the company’s proprietary transdermal
FDA Policy/General
Federal Register notice: FDA is seeking industry organizations interested in participating in selecting nonvoting industry representatives to serve on CDRH’s National Mammography Quality Assurance Advisory Committee. The agency is also requesting nominations for a nonvoting industry representative to serve on the committee. A nominee may either be self-nominated
Devices
FDA says it has qualified the IMAnalytics with MRIxViP1.5T/3.OT and BCLib extraction and evaluation tool through the Medical Device Development Tools (MDDT) program. An agency statement says this is the first computational modeling tool that can be used across a wide range of active implantable medical devices
Drugs
FDA has released the FDA-483 with seven observations from a 6/10-7/18 inspection at Exela Pharma Sciences, a Lenoir, NC, outsourcing facility. The observations were: * failing to establish and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile; * aseptic processing areas are
Drugs
A December CDER Webinar for NDA applicants and holders, patent holders, and regulatory professionals explains updates made to forms FDA 3542a and 3542. The presentation by CDER’s Alicia Chen says the forms were updated to (1) reduce the time needed to complete and process the forms, (2) update certain
Drugs
FDA has released for comment a draft guidance, FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act, to address early planning for pediatric evaluation of certain molecularly targeted oncology drugs, including biological products, for which original NDAs and
FDA Policy/General
The Senate 12/12 confirmed Stephen Hahn as the next FDA commissioner on a floor vote of 72-18. President Trump nominated the MD Anderson chief medical officer 11/1, the same day former acting commissioner Ned Sharpless was ordered back to his previous position as National Cancer Institute director.
Devices
FDA has authorized the de novo marketing of PerkinElmer’s GSP Neonatal Creatine Kinase-MM kit as an aid in newborn screening for Duchenne Muscular Dystrophy (DMD), a rare genetic disorder that causes progressive muscle deterioration and weakness. Newborn screening uses a small amount of blood from an infant’s
Drugs
FDA has approved an Elite Pharmaceuticals ANDA for a generic version of Shire’s Adderall XR (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate) in 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg tablets. The central nervous system stimulant is indicated for treating attention deficit
Drugs
On a near party-line 230-192 vote with only two Republicans joining all Democrats, the House approved 12/12 H.R. 3, the Elijah E. Cummings Lower Drug Costs Now Act. It now goes to the Senate where it will face significant opposition. President Donald Trump has already said
Drugs
Provention Bio says that as a result of a meeting with FDA staff to discuss the proposed contents of a BLA for its PRV-031 (teplizumab) for prevention or delay of Type 1 diabetes in at-risk individuals, it expects to open a rolling BLA submission mid-2020 and complete
Drugs
FDA has released for comment a draft guidance, FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act, to address early planning for pediatric evaluation of certain molecularly targeted oncology drugs, including biological products, for which original NDAs and
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Briviact (brivaracetam) oral solution and separately for an injectable formulation. The oral solution is indicated for adjunctive therapy in treating partial-onset seizures in patients 16 years of age and older with epilepsy, whereas the
Devices
FDA has cleared a Cochlear Ltd. 510(k) for the Cochlear Osia 2 System, an active osseointegrated steady-state hearing implant. The device uses digital piezoelectric stimulation to bypass damaged areas of the natural hearing system to send sound vibrations directly to the inner ear (cochlea), the company says. “The
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says an Alkermes print ad for Vivitrol (naltrexone for extended-release injectable suspension) for intramuscular use is false and misleading because it omits important risk information associated with using the drug. A 12/2 Warning Letter says the violation “is concerning from
Drugs
FDA has accepted for review a Novartis supplemental BLA for Xolair (omalizumab) for treating nasal polyps in adult patients 18 years of age and older with inadequate response to intranasal corticosteroids. The submission is based on results from the Phase 3 POLYP 1 and POLYP 2 trials, which showed Xolair
Drugs
The Senate voted 12/10 to approve on a 91-2 vote S. 2740, the Over-the-Counter Drug Safety, Innovation, and Reform Act, which its sponsors say will streamline and modernize FDA’s regulatory system. A statement from Sens. Johnny Isakson (R-GA) and Bob Casey (D-PA) says
Drugs
FDA’s Cardiovascular and Renal Drug Advisory Committee has voted 11-2 against recommending approval of Correvio Pharma’s vernakalant for use to rapidly convert recent onset atrial fibrillation to sinus rhythm. Panel members were concerned about safety issues, which included bradycardia, ventricular arrhythmias and deaths recorded in clinical trials.
Devices
FDA has cleared an ImpediMed 510(k) for Sozo, intended for use as an aid in assessing protein calorie malnutrition. Previously, the device was cleared as an aid in the early detection of secondary lymphedema, and determining fluid status for patients living with heart failure. The expanded clearance permits Sozo
FDA Policy/General
A recent DC federal court decision in a Centers for Medicare and Medicaid Services (CMS) case could be followed to a conclusion that courts may see FDA Warning Letters as final agency action. Attorney Michelle Yeary (Dechert) says in an online Drug and Device Law post that the case involved
Drugs
The Council for Responsible Nutrition (CRN), which represents dietary supplement and functional food manufacturers, says it applauds a Supreme Court decision not to hear an Amrin Pharma appeal of a lower court ruling in a fish oil case. In a statement, CRN says the decision “maintains FDA’s proper jurisdiction
Drugs
FDA says 25 unapproved drug, dietary supplement and medical device product lines distributed by Basic Reset and Biogenyx of Hendersonville, TN have been recalled. In September, a federal court approved a consent decree (see story) against the firms for unlawfully distributing the products. Products that have been recalled include drugs