Drugs
FDA has accepted for review a Mallinckrodt NDA for stannsoporfin, indicated for treating neonates at risk for developing severe hyperbilirubinemia, or severe jaundice. Stannsoporfin is a heme oxygenase inhibitor under investigation for its potential to reduce the production of bilirubin in at-risk infants. FDA has set a user fee
Drugs
FDA has accepted Shire’s BLA for lanadelumab and will give it a priority review for preventing angioedema attacks in patients age 12 and older with hereditary angioedema (HAE), a rare genetic disorder. The company says that if it is approved, lanadelumab will be the first monoclonal antibody for HAE,
Drugs
FDA says its review of the results of a 10-year follow-up study of patients with coronary heart disease further supports the risk of prescribing AbbVie’s antibiotic Biaxin (clarithromycin) and generics because of a potential increased risk of heart problems or death that can occur years later. An
Drugs
CNBC reports that despite pressure from President Donald Trump for Congress to pass “right-to-try” legislation giving terminally ill patients access to experimental drugs, FDA commissioner Scott Gottlieb is seeking changes in the legislation. In 8/2017, CNBC reports, the Senate passed on a unanimous vote a bill allowing
Drugs
A PricewaterhouseCoopers Health Research Institute report says FDA approved 763 generic drugs in 2017, up 14% from the 651 approved the previous year. The Washington Examiner reports that a major reason for the increased number of generic drug approvals was the agency’s year-long effort to speed the generic
Drugs
The Federal Trade Commission (FTC) says Telomerase Activation Sciences and its CEO have agreed to stop making false and unsupported claims about its two anti-aging products. FTC said the company lacked the scientific evidence to support claims that its capsules, powders, and creams could provide a broad range of
FDA Policy/General
Advisory Committee and the Microbiology Devices Panel of the Medical Devices Advisory Committee. On 3/21, panel members will discuss and make recommendations regarding a device reclassification from Class 3 to Class 2 of nucleic acid and serology-based point-of-care and laboratory-based in vitro diagnostic devices indicated
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Medical Device Labeling Regulations — 21 CFR parts 800, 801, and 809” (OMB Control Number 0910-0485). The collection addresses requirements for the label or labeling of a medical device so that it is not misbranded and subject
Drugs
FDA has accepted for review a Medicines360 supplemental NDA that seeks to extend the duration of use for preventing pregnancy from up to four years to up to five years for Liletta (levonorgestrel-releasing intrauterine system) 52 mg. The submission is based on additional efficacy and safety data from a
Devices
FDA has cleared an Access Vascular 510(k) for the HydroPICC, a peripherally inserted central catheter, intended for long-term use. In pre-clinical testing, the HydroPICC demonstrated a 30-times reduction in platelet count when compared with the current market-leading peripherally inserted central catheter, according to the company.
FDA Policy/General
Federal Register notice: FDA has announced a 4/19 Peripheral and Central Nervous System Drugs Advisory Committee meeting. Panel members are scheduled to discuss a GW Pharmaceuticals NDA for its cannabidiol oral solution, indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients
Drugs
FDA has accepted for filing a Medicines360 sNDA to extend the duration of use of its Liletta (levonogestrel-releasing intrauterine system) 52 mg from up to four years to up to five years. The company says the sNDA is currently being reviewed by the agency based on additional efficacy and
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should abandon its efforts to develop a devices referencing drugs (DRD) pathway, while the Advanced Medical Technology Association (AdvaMed) strongly endorses the proposal. In its comment letter. PhRMA says DRDs “pose numerous significant public health, safety, scientific, regulatory, and legal issues
Drugs
FDA has posted a Web page with links to documents relating to the long-term goal of improving the predictability and consistency of the electronic submission process and enhancing transparency and accountability of FDA information technology related activities. Under the heading of improving the predictability and consistency of PDUFA electronic
Devices
FDA has cleared a NeoTract 510(k) for new indications for the UroLift System to treat an enlarged prostate or benign prostatic hyperplasia. The expanded indications cover patients who have an obstructive median lobe and those as young as 45 years of age. Previously, the device was contraindicated in patients
Devices
FDA has cleared a Corindus Vascular Robotics 510(k) for the CorPath GRX System and its use in peripheral vascular interventions. The CorPath System is the only medical device to bring robotic precision to both percutaneous coronary intervention and peripheral vascular intervention procedures, the company says. During procedures, interventional cardiologists
Drugs
FDA says Divinity Products Distribution, Grain Valley, MS, has destroyed and recalled a large volume of kratom-containing dietary supplements it manufactured and distributed nationwide under three brand names. An agency news release says the company also agreed to stop selling all products containing kratom. “Based on the scientific evidence
Drugs
BIO says FDA should expand a draft guidance on developing targeted therapies in low-frequency molecular subsets of a disease to provide further thinking on the agency’s receptivity to innovative approaches for developing targeted therapies. In its comment, BIO also recommends the draft guidance reflect a scenario in which
Drugs
FDA has sent a second complete response letter to Apricus Biosciences on its NDA for Vitaros (alprostadil topical cream) for treating erectile dysfunction. The company says the letter indicates that the agency cannot approve the submission in its present form, identifying deficiencies related to chemistry, manufacturing and controls and certain
Drugs
FDA has accepted for review an Acorda Therapeutics NDA for Inbrija (inhaled levodopa) for treating symptoms of Off periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen. The agency has set a user fee review action target date of 10/5. The submission includes data from a
FDA Policy/General
Federal Register final rule: FDA has amended its regulations on data acceptance from clinical investigations for medical devices conducted outside the U.S. to support a device submission to require that such studies be conducted in accordance with good clinical practice. This includes obtaining and documenting the review and approval
Drugs
Pfizer and several other stakeholders are asking FDA to provide more detail on how it will incorporate patient experience into regulatory decisions such as benefit/risk considerations. “For example,” Pfizer says in a comment letter on an agency patient-focused drug development (PFDD) discussion document, “it would be helpful to