Drugs
Eli Lilly says it is discontinuing its Phase 3 development program for JAK inhibitor Olumiant (baricitinib) in adults with active systemic lupus erythematosus based on top-line efficacy results from two pivotal Phase 3 trials (SLE-BRAVE-I and II). “In SLE-BRAVE-I, the baricitinib 4-mg oral dose
Drugs
For the second time in three days, an accelerated approval application has been withdrawn due to disagreements with FDA over confirmatory/post marketing study commitments. On 1/28, Regeneron Pharmaceuticals and Sanofi withdrew their supplemental BLA for Libtayo (cemiplimab-rwlc) as a second-line treatment for patients with advanced cervical
FDA Policy/General
FDA commissioner nominee Robert Califf is reportedly losing Senate backing and the White House has been slow to help advance his confirmation standing. Five Democrats — Sens. Bernie Sanders (I-VT), Joe Manchin (D-WV), Ed Markey (D-MA.), Maggie Hassan (D-NH) and Richard Blumenthal (D-CT) — have signaled opposition
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Revising ANDA Labeling Following Revision of the RLD Labeling.” This guidance provides recommendations for updating ANDA labeling following revisions to the reference-listed drug (RLD) labeling, including information on how to identify RLD labeling updates and how to submit
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Information Requests and Discipline Review Letters Under GDUFA.” The document explains how FDA will issue and use an information request and discipline review letter during the assessment of an original ANDA. To view the notice, click here.
Drugs
A Congressional Budget Office (CBO) report on trends in nationwide spending on prescription drugs for 1980-2018 finds that since the mid-2000s, per capita spending on prescription drugs has fallen as a percentage of total spending on healthcare services and supplies. The slower growth in spending is associated with
Drugs
FDA has just released an Establishment Inspection Report (EIR) from a 9/5/2019-9/13/2019 inspection at Emergent BioSolutions Canada, Winnipeg, Manitoba, and an FDA-483 with one inspection observation from that inspection. The company is a contract manufacturer of sterile human drugs. The one observation on the
Drugs
FDA has just released a 9/16/2021 Notice of Violation issued to Hopkinton Drug, a Hopkinton, MA, sterile drug producer, following an 8/25-11/2/20 inspection that identified deficiencies in the company’s practices for producing drug products that put patients at risk. The letter says the
FDA Policy/General
Federal Register notice: FDA has announced a 4/12 virtual public meeting entitled “Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards.” The meeting fulfills FDA’s commitment to seek stakeholder input related to data standards and the electronic submission system’s past performance, future targets, emerging
FDA Policy/General
Federal Register notice: FDA has evaluated certain substances that have been nominated for inclusion on a list of bulk drug substances (i.e., active pharmaceutical ingredients) for which there is a clinical need (the 503B Bulks List). Drug products that outsourcing facilities compound using bulk drug substances on the 503B
Drugs
FDA says that in FY 2020, the percentage of regulatory actions for OAI (official action indicated) drug manufacturing facilities completed within six months of inspection closing dropped to 63% from 74% in FY 2019. In both fiscal years, the performance measure for issuing a final facility classification letter within 90
FDA Policy/General
Former FDA deputy commissioner for medical and scientific affairs Anand Shah has joined Big Health’s board of directors. Shah is being asked to help expand access to digital therapeutics as non-drug alternatives for mental health care, the company says, adding that he will take an active role in
FDA Policy/General
Law firm Hogan Lovells has added former FDA investigator Chris Middendorf as the firm’s regulatory affairs director. In this capacity, Middendorf will assist life sciences clients with regulatory and policy issues, such as product quality and manufacturing issues, and related compliance with FDA requirements for pharmaceuticals and biological products.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Good ANDA Submission Practices.” The document highlights common, recurring deficiencies that may lead to an ANDA approval delay. It also makes recommendations to applicants on how to avoid the deficiencies and minimize the number of review cycles. To view
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says an Eli Lilly social media post for Trulicity (dulaglutide) injection, for subcutaneous use, “makes false or misleading claims and representations about the benefits and risks of Trulicity.” A 1/19 Notice of Violation says the FDA Bad Ad program received a
Devices
Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) are urging FDA to quickly finalize its proposed rule on over-the-counter (OTC) hearing aids. In a statement (contains a link to the letter), the senators say the proposed rule is a result of their Over-the-Counter Hearing
FDA Policy/General
Hanzo compliance product manager Will Walker says FDA-regulated companies need to have fully functional, interactive Web site archives that they can use to prove to FDA that their advertising and promotional content was and is in compliance with regulations. Writing in an online post, Walker says that without an
Biologics
FDA would have many responsibilities in the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act) released 1/25 by Sens. Patty Murray (D-WA) and Richard Burr (R-NC), the chair and ranking member of the Senate HELP Committee. Murray and Burr
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation.” The document describes principles that should be considered when using such instruments in evaluating medical devices and provides recommendations about the importance
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Patient Engagement in the Design and Conduct of Medical Device Clinical Studies.” The document was developed based on a recommendation by the agency’s Patient Engagement Advisory Committee for a framework to clarify how patient advisors can engage in
Devices
CDRH has issued the 2021 annual report on the Accreditation Scheme for Conformity Assessment pilot program. The program is designed to enhance the use of declarations of conformity that should translate into greater consistency and predictability in the agency’s approach to assessing conformance to standards in medical device review
Drugs
FDA has published a guidance, Good ANDA Submission Practices, to assist applicants preparing to submit ANDAs to the agency. The document highlights common recurring deficiencies that may lead to a delay in approving an ANDA. It also makes recommendations to applicants on how to avoid the deficiencies to minimize the