Drugs
The House has passed bipartisan legislation intended to improve drug quality, reduce drug shortages, and make pharmaceutical production more efficient. The National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing Act, sponsored by Rep. Frank Pallone (D-NJ), would allow FDA to partner with universities with experience in drug
Drugs
FDA has issued Stealth BioTherapeutics a refuse-to-file letter on its NDA for elamipretide, a mitochondria-targeted therapy for treating Barth syndrome. The agency letter said the NDA does not contain an adequate and well-controlled trial that provides evidence of effectiveness, according to the company. It said that
Devices
A 6/3-7/15 FDA inspection at Magnolia Medical Technologies, Seattle, WA, found Quality System regulation violations in the firm’s work as a specification developer for the Steripath Gen 2 blood collection system. A 9/17 Warning Letter says specific violations were: * failing to establish and maintain adequate
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products. The updated document is intended to describe hearing aids, personal sound amplification products, their respective intended uses, and the regulatory requirements that apply to them. To view the
FDA Policy/General
Federal Register proposed rule: FDA is proposing to establish a regulatory category for over-the-counter (OTC) hearing aids and to make related amendments to update the regulatory framework for such devices. Specifically, it seeks to define OTC hearing aids and establish applicable requirements; amend existing rules for consistency with
Drugs
The Utah federal court has entered a consent decree of permanent injunction between the U.S. government, through FDA, and Grandma’s Herbs, St. George, UT, and its owners, Kevin and Tracey Parr. An FDA news release says the company manufactured and distributed products marketed as dietary supplements with labeling
Drugs
A 4/13-26 FDA inspection at Sircle Laboratories, a Madison, MS, drug manufacturing facility, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 9/21 Warning Letter says specific violations were: * failure of the firm’s quality control unit to exercise its responsibility to
Drugs
FDA has granted Akero Therapeutics a fast track designation for efruxifermin and its use in treating non-alcoholic steatohepatitis (NASH). The drug is currently being evaluated in two parallel Phase 2b clinical trials in NASH patients, one (HARMONY study) in adult patients with F2/F3 fibrosis and a second (SYMMETRY
Devices
FDA will accept comments for 90 days on a proposed rule to establish a regulatory category for over-the-counter (OTC) hearing aids and to make related amendments to update the hearing aid regulatory framework. In the proposed rule, FDA says it will: * define OTC hearing aids and establish applicable
FDA Policy/General
Federal Register notice: FDA is amending the animal drug regulations to reflect application-related actions for new animal drug applications, abbreviated new animal drug applications, and conditional new animal drug applications during January, February, and March. FDA is also informing the public about the availability of basis of approval summaries
Drugs
FDA has approved an Adamis Pharmaceuticals NDA for Zimhi (naloxone HCl injection, 5 mg/0.5 mL) for treating opioid overdose. Naloxone is an opioid antagonist and works by blocking or reversing the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness, according to the company.
Drugs
Melinta Therapeutics is asking FDA to take several actions on a Nexus Pharmaceuticals ANDA that relies on Melinta’s Minocin (minocycline) 100 mg/vial as the reference-listed drug. A Melinta 10/16 petition says there are issues with the Nexus ANDA related to Melinta’s offices being closed in
Devices
FDA has cleared an SPR Therapeutics 510(k) for a broader indication for use for its Sprint Peripheral Nerve Stimulation (PNS) System. The device’s previous clearance limited its use to the back and extremities, but the new indication allows it to also be used in areas of the head,
Drugs
FDA has approved an Oyster Point Pharma NDA for Tyrvaya (varenicline solution) nasal spray 0.03 mg for treating signs and symptoms of dry eye disease. The product is believed to “bind to cholinergic receptors to activate the trigeminal parasympathetic pathway resulting in increased production of basal tear film as
Biologics
FDA says two physician researchers at Minneapolis’ Hennepin County Medical Center failed to submit INDs for the conduct of clinical investigations with investigational new drugs. The agency just released a 5/5 Warning Letter to Jon Cole and a 5/6 Warning Letter to Lauren Klein detailing issues with Cole’
FDA Policy/General
Sen. Richard Blumenthal (D-CT) says he will likely oppose Duke University School of Medicine professor Robert Califf’s potential nomination to be the next FDA commissioner. Califf’s name is the latest to be floated for the agency top job (see earlier story). Califf was commissioner for less than
Drugs
An FDA 5/3-5/14 inspection at Marcus Research Laboratory, a St. Louis, MO, drug manufacturing facility, identified significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 9/30 Warning Letter says specific deviations were: * failing to have the procedures and processes necessary
Biologics
FDA has issued Revance Therapeutics a complete response letter on its BLA for daxibotulinumtoxinA for Injection and its use in treating moderate to severe glabellar (frown) lines. The letter, according to the company, said the agency was unable to approve the submission due to deficiencies related to an onsite inspection
Drugs
FDA has issued Omeros a complete response letter on its BLA for narsoplimab as a treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). In the letter, according to the company, FDA said it had difficulty in estimating the treatment effect of narsoplimab in HSCT-TMA and requested
Drugs
FDA is reminding in vitro diagnostic manufacturers that the agency requires an institutional review board (IRB) review for all device clinical investigations that involve human subjects, including those that use leftover, deidentified human specimens in FDA-regulated studies. “This requirement pertains to data used to support an investigational device exemption,
Drugs
FDA has issued United Therapeutics a complete response letter on its NDA for Tyvaso DPI (treprostinil) for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease to improve exercise capacity. FDA’s letter, according to the company, cited a deficiency related to an open inspection issue
Biologics
FDA has approved a Boehringer Ingelheim Pharmaceuticals supplemental BLA for Cyltezo (adalimumab-adbm), an interchangeable biosimilar that will allow pharmacy substitutions without prescribers’ concurrence. Cyltezo was originally approved 8/2017 as a biosimilar version of Abbott’s Humira (adalimumab) for multiple inflammatory diseases. “Interchangeable biosimilar products can be expected to