FDA Policy/General
Federal Register proposed rule: FDA has proposed to repeal a regulation that requires an FDA-approved NDA or ANDA for any drug product that is sterilized by irradiation. Repealing the irradiation regulation would mean that over-the-counter drug products that are generally recognized as safe and effective, that are
FDA Policy/General
Federal Register notice: FDA has announced a 10/10 Oncologic Drugs Advisory Committee meeting to review a Celltrion BLA for a proposed biosimilar to Genentech’s Rituxan (rituximab). The proposed indications are for the treatment of adult patients with (1) relapsed or refractory, low-grade or follicular, CD20-positive, B-
FDA Policy/General
Federal Register notice: FDA has announced a public workshop entitled “Evidence-Based Treatment Decision in Transplantation: Patient Individualized Treatment; Choosing the Right Regimen for the Right Patient.” The workshop is intended to discuss potential candidate biomarkers to determine organ transplant patients’ immunologic risk for organ rejection or tolerance. It will
Devices
FDA commissioner Scott Gottlieb and CDRH director Jeffrey Shuren say that as part of the agency’s FY 2019 budget they are proposing to create a Center of Excellence for Digital Health to advance modernizing FDA’s regulatory approach to help the industry grow and reach its full potential while
Drugs
FDA has released the FDA-483 issued following an 8/20-8/28 inspection at Liva Pharmaceuticals, Gujarat, India. The document lists these inspection observations: * procedures designed to prevent microbiological contamination of sterile small volume parenteral drug products purporting to be sterile are not followed; * aseptic processing areas are deficient
Drugs
FDA has accepted for review a Sanofi and Regeneron Pharmaceuticals supplemental BLA for Praluent (alirocumab) to update the Prescribing Information to include its effect in reducing the overall risk of major adverse cardiovascular events (MACE). MACE is a catch-all term that includes heart attack, ischemic stroke, death from coronary
Drugs
FDA has granted Syntimmune an orphan drug designation for SYNT001 for treating pemphigus. The designation is based on positive preliminary results from a Phase 1b proof-of-concept trial in pemphigus patients, a rare and severe autoimmune disease that leads to painful blistering. Data showed that SYNT001 appeared to be
Biologics
FDA has accepted for priority review a supplemental BLA for Keytruda, an anti-PD-1 therapy, as monotherapy for first-line treatment of locally advanced or metastatic nonsquamous or squamous non-small cell lung cancer (NSCLC) in patients whose tumors express PD-L1 without EGFR or ALK genomic tumor aberrations.
Drugs
FDA has issued a guidance, Comparative Clinical Endpoint Bioequivalence Study Analysis Datasets for Abbreviated New Drug Applications, with recommended technical specifications and general considerations on how certain comparative clinical endpoint bioequivalence study data and skin adhesion and irritation/sensitization study data from ANDAs should be submitted using FDA-supported data
Drugs
A Tufts Center for the Study of Drug Development analysis of 509 drugs and biologics approved by FDA from 2000 to 2017 found that central nervous system (CNS) drugs take 20% longer to develop and approve versus non-CNS products. “Due to the complex nature of the conditions they are
Devices
FDA inspections at Medtronic Puerto Rico Operations Company, Juncos, Puerto Rico, and Medtronic’s Cardiac Rhythm and Health Failure business, Mounds View, MN, found violations of FDA regulations, according to Warning Letters sent to each facility. The 8/23 Puerto Rico Operations Warning Letter says investigators found Quality System regulation
Devices
The HHS Inspector General (IG) says FDA should promote use of presubmission meetings to address cybersecurity-related questions, include cybersecurity documentation as a criterion in the agency’s Refuse-to-Accept checklist, and include cybersecurity as an element in its “Smart” template. The recommendations are in a study report that
FDA Policy/General
Federal Register notice: FDA has announced a 10/11 Anesthetic and Analgesic Drug Products Advisory Committee meeting. Panel members are scheduled review a Trevena NDA for oliceridine 1mg/ml injection for managing moderate-to-severe acute pain in adult patients for whom an intravenous opioid is warranted. The committee will
FDA Policy/General
Federal Register notice: FDA has announced a 10/17 Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee joint meeting. The committees are scheduled to discuss a Sloan Pharma supplemental NDA for Zelnorm (tegaserod maleate) tablets that are proposed for treating women with irritable bowel syndrome
Drugs
A 12/4-12/12/17 FDA inspection at Lernapharm (Loris), Montreal, Canada, found significant violations of current good manufacturing regulations for finished pharmaceuticals, according to a 9/4 Warning Letter to the company. Specific violations cited in the letter were: * failing to establish and follow appropriate written procedures that
Drugs
The Biotechnology Innovation Organization (BIO) applauds an FDA draft guidance with recommendations on general principles to consider when drafting an indication and how to write, organize, and format the information in the Indications and Use section of labeling. The BIO letter particularly commends the agency for recognizing that an indication
Drugs
An FDA 8/27-8/31 inspection at the Lupin Tarapur, India, drug manufacturing facility closed with one inspection observation that the company termed a “procedural deficiency” in a statement to news media in India. The statement says the inspection focused on cGMP compliance and also on the safety of
Drugs
A 9/25-9/29/17 FDA inspection at Longwood Medicine (Beijing) Co., Beijing, China, found significant violations of current good manufacturing practices (CGMP) for finished pharmaceuticals. An 8/27 Warning Letter says specific violations were: * failing to establish an adequate quality control unit with the responsibility and authority to
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Postapproval Changes to Drug Substances.” The document covers facility, scale, and equipment changes associated with all steps of drug substance manufacturing; specification changes to starting materials, raw materials, intermediates, and the unfinished and final drug substance; synthetic manufacturing process
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension “Guidance for Industry: Formal Meetings between the Food and Drug Administration and Biosimilar Biological Product Sponsors or Applicants,” (OMB Control No. 0910–0802). To view the notice, click here.
FDA Policy/General
Former FDA chief counsel Rebecca Wood has rejoined Sidley Austin to co-lead both the firm’s food, drug and medical device regulatory practice and its FDA group in Washington with partner Coleen Klasmeier. Wood left FDA in July after serving a year in the Trump Administration as the agency’
Devices
Cook Medical has received an FDA close-out letter resolving a 2014 Warning Letter for processes related to the company’s quality system at its manufacturing facility in Bloomington, IN. The Warning Letter from the Detroit District Office said that violations noted in the inspection included: * failing to validate, with