Drugs
After 28 years at FDA, CDER Office of Process and Facilities (OPF) acting deputy director David Doleski is leaving next month to accept the position of biologics compliance head at Sanofi Genzyme. At OPF, which is part of the Office of Pharmaceutical Quality (OPQ), Doleski had responsibility for integrating inspection
Drugs
FDA has accepted for priority review an AstraZeneca supplemental NDA for the use of Lynparza (olaparib) tablets in patients with germline BRCA-mutated, HER2-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic settings. The submission is based on the positive results
Drugs
FDA has released two identical FDA-483s issued 4/26 and 5/3 following a 4/20-4/26 agency inspection at Akorn, Inc., Decatur, IL. The inspection observations were: * the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed; * equipment used in
Drugs
FDA has accepted a Pacira Pharmaceuticals supplemental NDA resubmission seeking expansion of its Exparel (bupivacaine liposome injectable suspension) label to include administration via nerve block for prolonged regional analgesia. The agency has set a user fee review action target date of 4/5/2018. Exparel is currently indicated for single-
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension request for “Medical Devices; Device Tracking — 21 CFR Part 821.” FDA is given discretion in applying tracking provisions to medical devices meeting certain criteria and provides that tracking requirements for medical devices can be imposed only after it
Drugs
FDA has released the FDA-483 issued following a 2/20-3/24 inspection at Pfizer’s Meridian Medical Technologies combination drug/device manufacturer, whose products include the EpiPen, in Brentwood, MO. The 14 inspection observations were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch
Devices
FDA has cleared an Instrumentation Laboratory 510(k) for the HemosIL AcuStar HIT-IgG(PF4-H) Assay and HemosIL AcuStar HIT Controls. The assay is described by the company as the “first on-demand, fully automated, chemiluminescent reagent on a hemostasis testing system for the qualitative detection of platelet factor
Devices
[Analysis by Jim Dickinson] Billed in a news release as a “pioneering event,” FDA recently held the first meeting of its CDRH-created Patient Engagement Advisory Committee (PEAC), an event which commissioner Scott Gottlieb hailed as “a significant step forward in the FDA’s efforts to broaden its engagement with
FDA Policy/General
Federal Register notice: FDA has classified nucleic acid-based devices for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens into Class 2 (special controls). The classification requested was submitted in a 5/2014 de novo petition from T2 Biosystems for the T2Candida Panel and T2Dx
Drugs
FDA has accepted for priority review an AstraZeneca supplemental BLA for Imfinzi (durvalumab) for treating patients with locally advanced, unresectable non-small cell lung cancer whose disease has not progressed following platinum-based chemoradiation therapy. Currently, the standard of care for these patients with locally advanced (Stage 3) lung cancer
FDA Policy/General
Federal Register notice: FDA has classified automated image assessment systems for microbial colonies on solid culture media into Class 2 (special controls). The action is the result of a 12/2015 de novo petition from Clever Culture Systems AG for its APAS Compact. The agency has named the generic type
Devices
A 5/10-5/30 FDA inspection at Kelynian Global, Canton, CT, found Quality System Regulation violations in the firm’s manufacturing of patient-specific cranial implants and maxillofacial implants, according to a 10/5 Warning Letter. Specific violations listed on an FDA-483 were: * failing to establish and maintain
Devices
In what may be a targeted inspection crackdown by FDA, Diasol has been issued its third Warning Letter this month, with each letter addressing deficiencies at a different facility. The latest Warning follows a 6/6-6/21 agency inspection at the firm’s facility in San Fernando, CA, that
Drugs
CDER Office of Generic Drugs director Kathleen Uhl and Office of Pharmaceutical Quality director Michael Kopcha say the recent reauthorization of the Generic Drug User Fee Amendments (GDUFA) is a “victory for public health. Increasing consumer access to safe, high-quality, and affordable generic drugs is a top priority at
Devices
FDA has cleared a DePuy Synthes 510(k) for its recently launched Maxframe Multi-Axial Correction System, an external circular fixation device used to gradually correct bone or soft tissue deformities in the arm, leg, foot or ankle. The device is indicated for the following treatments in adults and in
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Diasol, Inc. San Fernando, CA (9/25): FDA inspected the firm in June and cited GMP deviations with liquid and powder dialysate concentrate products and liquid and powder sodium
Drugs
The International Council for Harmonization (ICH) says it has adopted a new guidance relating to clinical trials in children that complements one from 2000. The new document, it says in a news release, addresses new scientific and technical knowledge advances in pediatric drug development and updates certain aspects of the
Drugs
Teva Pharmaceutical Industries has submitted a BLA for fremanezumab, an anti-calcitonin gene-related peptide monoclonal antibody for preventing migraine headaches. The submission is based on data from Phase 3 studies that “demonstrated a significant reduction in the number of migraine and headache days, acute medication use and disability, in
Drugs
Three Gibson, Dunn & Crutcher attorneys write in a WLF Legal Pulse published by Washington Legal Foundation that a Federal Trade Commission (FTC) suit against Shire is the latest development in the FTC’s well-established program for enforcing antitrust laws where it feels generic competition is being blocked or
Drugs
A Kentucky federal judge has dismissed six of seven allegations in a suit against Zydus Pharmaceuticals, a manufacturer of a generic form of Wyeth’s Cordarone (amiodarone hydrochloride). The suit’s plaintiff says she suffered blindness due to amiopdarone toxicity after taking the drug to treat atrial fibrillation, an off-
FDA Policy/General
Federal Register notice: FDA has classified enzyme packed cartridges into Class 2 (special controls). The action is the result of a 1/2015 de novo submission from Alcresta, Inc. for Relizorb. The agency has named the generic type of device “enzyme packed cartridge,” and it is identified as an ex
FDA Policy/General
Federal Register notice: FDA is correcting a 9/21 Federal Register notice that announced the withdrawal of approval of 27 abbreviated new drug applications (ANDAs) from multiple applicants. The document was published with the incorrect docket number. The correct docket number is: FDA – 2017 – N – 5226. To view the notice,