Drugs
FDA has issued a final guidance on Certificates of Confidentiality, which describes the agency’s implementation of revised provisions under the 21st Century Cures Act (Cures Act). A Certificate of Confidentiality (CoC) is intended to help protect the privacy of human subject research participants when identifiable, sensitive information is being
Drugs
FDA has issued a complete response letter (CRL) for the Alkermes NDA for its ALKS 3831 (olanzapine/samidorphan) for treating adults with schizophrenia and bipolar 1 disorder. The letter indicates that FDA requires the resolution of certain conditions related to the tablet coating process at the firm’s Wilmington, OH,
Drugs
FDA meetings with industry on product development issues are suffering from fewer interactions and participation due to Covid-19 and the necessary move to virtual presentations and discussions, CDER deputy Center director for clinical science Bob Temple told the virtual Prevision Policy/Friends of Cancer Research Biopharma Congress last month.
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Family Pharmacy, Statesville, NC (11/6): FDA inspected the firm 2/3-2/12 and cited multiple drug compounding and GMP violations. For example, it failed to establish an
Devices
Federal Register notice: FDA has made available a draft guidance entitled Electromagnetic Compatibility of Medical Devices. The document describes relevant information that should be provided in device premarket submissions. To view the notice, click here.
Drugs
An 11/19 Biosimilar User Fee Act (BsUFA) reauthorization public meeting is likely to hear proposals for potential enhancements or efficiencies for the biosimilar product development and review process. That’s an expectation voiced by CDER Office of Therapeutic Biologics and Biosimilars director Sarah Yim in a CDER Conversation. She
Devices
A 10/22 CDRH Webinar provided background information and an overview of the Accreditation Scheme for Conformity Assessment (ASCA) pilot program. In the presentation, CDRH Standards and Conformity Assessment Program senior policy analyst Stacy Cho said that during the MDUFA 4 reauthorization negotiations, FDA and industry agreed to establish a
Drugs
Representatives Brendan Boyle (D-PA), Scott Perry (R-PA) and Madeleine Dean (D-PA) have introduced the Alternatives to Animals for Regulatory Fairness (AARF) Act to modernize the drug approval process. “The AARF Act ensures that pharmaceutical companies are allowed to use high-tech and humane alternatives to outdated testing
Drugs
Moderna says its investigational Covid-19 vaccine is showing a 94.5% efficacy rate based on a NIH-appointed data safety monitoring board interim analysis. The COVE study, which enrolled more than 30,000 participants to evaluate the company’s messenger RNA vaccine (mRNA-1273) has reached 95 Covid-19
FDA Policy/General
FDA commissioner Stephen Hahn says that over the past year the agency has seen about 1,000 net growth in staff due to a streamlined hiring spree authorized by the recent CURES Act. “For FY 20, the FDA hired 2,308 staff (and lost 1,281) with a total net
Drugs
FDA has issued Adamis Pharmaceuticals another complete response letter (CRL) on its NDA for Zimhi, a high-dose naloxone injection product for treating opioid overdose. The letter provided recommendations to support the NDA’s resubmission. “The questions raised by the FDA related generally to new chemistry, manufacturing and controls issues,
Devices
FDA has made available a draft guidance entitled Electromagnetic Compatibility (EMC) of Medical Devices. The document provides recommendations about information that should be provided in medical device submissions to demonstrate the EMC for electrically powered devices with electrical or electronic functions. The agency says that typically the review of EMC
Drugs
Federal Register notice: FDA has made available a final guidance #197 entitled Documenting Electronic Data Files and Statistical Analysis Programs. The document provides recommendations for documenting electronic data files and statistical analyses submitted to CVM to support new animal drug applications. To view the notice, click here.
Drugs
FDA has issued Sanofi a complete response letter (CRL) on its BLA for sutimlimab, an investigational monoclonal antibody for treating hemolysis in adults with cold agglutinin disease. The letter refers to deficiencies identified by the agency during a pre-license inspection of an unnamed third-party facility responsible for manufacturing,
FDA Policy/General
Oncologic Panel to Review GSK Myeloma BLA Federal Register notice: FDA announces a 12/14 online/teleconferencing Oncologic Drugs Advisory Committee meeting that will review a GlaxoSmithKline BLA for belantamab mafodotin, indicated for treating certain adults with relapsed or refractory multiple myeloma. 11/13/2020 Notice Corrected on ANDAs Withdrawn
Drugs
Boston Scientific has agreed to pay $75 million for some of the manufacturing assets and capabilities of Neovasc, which makes products for the cardiovascular market, including components for transcatheter heart valves such as Boston Scientific’s Lotus Valve System. Boston Scientific developed Lotus for transcatheter aortic valve replacement in order
Drugs
CDER director Janet Woodcock, who has been temporarily assigned to work with the Trump administration’s Operation Warp Speed, says the nation’s medical infrastructure has learned things during the Covid-19 pandemic that should lead to changes in the way things are organized for future infectious disease problems. Participating
Drugs
Heron Therapeutics has resubmitted to FDA its NDA for HTX-011, an investigational agent for managing postoperative pain. A company statement says the NDA was resubmitted based on the outcome and final minutes of a September Type A end-of-review meeting with the agency that discussed what was needed
Devices
FDA has granted 510(k) clearance for the use of Lantheus’ artificial intelligence-enabled automated bone scan index product on the GE Healthcare Xelerix platform. The company describes it as a vendor-neutral standalone software as a medical device that calculates the automated bone scan index in Technetium-99m bone
Drugs
Two suits filed by Nexus Pharmaceuticals against two drug compounding firms were dismissed by a California federal court under implied preemption as stated in Buckman v. Plaintinffs Legal Committee. Attorney James Beck (Reed Smith) says in an online post that the court said the suits were preempted because Nexus challenged
Drugs
FDA has granted orphan drug designation for Agios Pharmaceuticals’ first-in-class pyruvate kinase R (PKR) activator mitapivat for treating patients with sickle cell disease. The company says mitapivat is an investigational, oral, small molecule allosteric activator of wild-type and a variety of mutated PKR enzymes. It previously was
Drugs
The Justice Department says a Virginia federal court sentenced Indivior Solutions to pay $289 million in criminal penalties in connection with a previous guilty plea related to its marketing of Suboxone. The judge entered the sentence under a plea agreement. Altogether, a Justice Department statement says, Indivior Solutions will pay