Devices
FDA has posted a draft guidance on “Soft (Hydrophilic) Daily Wear Contact Lenses – Performance Criteria for Safety and Performance Based Pathway.” The document provides performance criteria for such devices if sponsors opt to use the alternative pathway to support substantial equivalence, instead of a direct comparison of a predicate device’
Drugs
Teva says it is generally pleased with an FDA draft guidance on product development and quality considerations for transdermal and topical delivery systems but believes there are some technical issues that require further clarification. The company’s comment letter raises several line-by-line technical issues for clarification. Mylan says
Devices
A 7/29-8/1/19 FDA inspection at Silfradent Srl, Santa Sofia, Italy, found violations of the Quality System regulation in the firm’s manufacturing of the Surgybone SB 300NA. A just-released Warning Letter says specific violations were: * failing to establish and maintain procedures to control the device
Drugs
KemPharm has submitted a 505(b)(2) for serdexmethylphenidate, indicated for treating attention deficit hyperactivity disorder. Serdexmethylphenidate is KemPharm’s prodrug of d-methylphenidate, the company says, adding that it has a 30 minute onset of action, a duration effect of 13 hours, and avoids unnecessary spikes in d-methylphenidate
Devices
FDA and the Centers for Disease Control and Prevention have taken action to make more respirators available to health care personnel. Most respirators on the market today are indicated for use in industrial settings, an FDA notice says. The action grants an emergency use authorization to allow certain National Institute
Devices
FDA is informing patients, healthcare providers, and manufacturers about the SweynTooth family of cybersecurity vulnerabilities that may introduce risks for certain medical devices. An agency online notice says FDA is not aware of any confirmed adverse events related to the vulnerabilities. “Software to exploit these vulnerabilities in certain situations is
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Acino Products, Hamilton, NJ (2/10): FDA inspected the company in 6/2019 and cited GMP violations for finished pharmaceuticals. For example, Acino failed to maintain buildings used in
Devices
FDA says a 7/18-7/30/19 inspection at CPAPNEA Medical Supply, Phoenix, AZ, determined that the company manufactures the Optipillows EPAP mask that is adulterated because the company does not have an approved PMA in effect for the device. A 1/23 Warning Letter says the device is
Drugs
In 3/3 letters to FDA and drug industry associations, Public Citizen says it is important that all drug shortages related to the Covid-19 epidemic be publicly identified. FDA announced the first related medication shortage 2/27, Public Citizen says in a letter to FDA commissioner Stephen Hahn, but
Devices
FDA has cleared an FX Shoulder 510(k) for its Glenoid Baseplate with a Central Screw and 32mm Glenosphere and Humeral Cups for reverse shoulder arthroplasty. The device features seven different central screw size length options ranging from 8mm to 20mm in 2mm increments. The company says that the 32mm
Drugs
Sandoz has agreed to pay a $195 million criminal penalty under a deferred prosecution agreement in an ongoing generic drug price-fixing investigation. A four-count felony charge was filed 3/2 in the U.S. District Court for the Eastern District of Pennsylvania, charging Sandoz with participating in four
Devices
As the coronavirus outbreak grows in the U.S., including two deaths over the weekend related to the illness, FDA has announced a new policy to permit certain laboratories to use tests they develop and validate to improve the testing capacity in the U.S. Earlier test kits developed by
FDA Policy/General
Federal Register notice: FDA has determined that CIS Bio International’s Neo Tect Kit was not withdrawn from sale for safety or effectiveness reasons. The determination will allow FDA to approve ANDAs that reference the product if all other legal and regulatory requirements are met. The scintigraphic imaging agent is
FDA Policy/General
Federal Register notice: FDA has determined the regulatory review period for patent extension purposes for Merck’s Ilumya (tildrakizumab), indicated for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The review period is 3,452days, which includes 3,089 days that occurred
Devices
FDA has released a final guidance on “Bone Anchors — Premarket Notification (510(k))Submissions.” The document provides submission recommendations for bone anchor (suture anchor) devices, which are indicated for attaching soft tissue to bone. It clarifies and provides current thinking on performance testing recommendations and device descriptions. Additionally, it addressed
FDA Policy/General
CDER’s Office of Prescription Drug Promotion (OPDP) has issued Outlook Pharmaceuticals a Warning Letter over a “sponsored link” on Google’s search engine for Procentra (dextroamphetamine sulfate) oral solution because there is no risk information included in the link. The drug is indicated for treating Attention Deficit Hyperactivity Disorder.
Drugs
FDA has approved a Biohaven Pharmaceutical Holding NDA for Nurtec ODT (rimegepant) for the acute treatment of migraine in adults. The quick dissolving product is intended to provide pain relief and return patients to normal function within one hour, the company says. The drug is not indicated for preventing migraines,
Drugs
Sanofi-Aventis has agreed to pay almost $12 million to resolve allegations that it violated the False Claims Act by paying kickbacks to Medicare patients taking its multiple sclerosis drug Lemtrada through a purportedly independent charitable foundation, The Assistance Fund. The Anti-Kickback Statute prohibits drug companies from offering or
Drugs
FDA has accepted for review a Pfizer and Eli Lilly BLA for tanezumab 2.5 mg administered subcutaneously for patients with chronic pain due to moderate-to-severe osteoarthritis who have experienced inadequate pain relief with other analgesics. The monoclonal antibody is part of an investigational class of non-opioid
Biologics
FDA has approved a Sanofi BLA for Sarclisa (isatuximab-irfc) in combination with pomalidomide and dexamethasone (pom-dex) for treating adults with relapsed refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Sarclisa is a monoclonal antibody that binds to the CD38
FDA Policy/General
CDRH 510(k) eSubmission Template Pilot Federal Register notice: CDRH has announced a voluntary “Electronic Submission Template and Resource (eSTAR) Pilot.” 02/27/2020 Standardized Medicated Feed Assay Limits Guide Federal Register notice: FDA makes available a draft guidance for industry #264 entitled “Standardized Medicated Feed Assay Limits.” 02/27/
FDA Policy/General
Celgene has agreed to acquire for $7 billion Impact Biomedicines and its JAK inhibitor program targeting myelofibrosis. Privately-held Impact is developing fedratinib, a highly selective JAK2 kinase inhibitor, for patients with treatment-naïve myelofibrosis, a bone marrow disorder that disrupts normal production of blood cells. Impact picked up fedratinib