FDA Policy/General
Federal Register notice: FDA has made available a guidance that is immediately in effect guidance entitled “Compliance Policy for Combination Product Postmarketing Safety Reporting.” The document describes FDA’s compliance policy for combination product applicants and constituent part applicants and activities under FDA regulations that addresses combination product postmarketing safety
Drugs
FDA has approved an expanded indication for Seattle Genetics’ Adcetris (brentuximab vedotin) to treat adults with previously untreated stage 3 or 4 classical Hodgkin lymphoma (cHL) in combination with chemotherapy. An FDA media statement says Adcetris combines an antibody and a drug, allowing the antibody to direct the drug to
Drugs
FDA commissioner Scott Gottlieb and two colleagues say the agency is using new screening technology at international mail facilities (IMFs) to enable it to screen more packages to prevent illegal products with hidden drug ingredients from entering the U.S. Writing in an FDA Voice blog post, the three say
Drugs
FDA has approved a Teligent ANDA for halobetasol propionate ointment, 0.05%, indicated for treating a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Total brand and generic annual sales are reported to be about $31 million.
Drugs
FDA has granted Fennec Pharmaceuticals a fast track designation for Pedmark (sodium thiosulfate) for preventing cisplatin-related ototoxicity in pediatric patients with standard risk hepatoblastoma. There are currently no drugs approved in the U.S. for the condition, according to the company. The drug has been studied in two Phase
Drugs
Treatment effects from pivotal trials supporting FDA approval of novel therapeutics based on surrogate markers of disease are often larger than the treatment effects observed among post-approval trials using surrogate markers as trial endpoints, specifically for non-continuous surrogate markers, according to a study published online in BMC Medicine.
Drugs
FDA says it is releasing a draft guidance to provide more complete and relevant information on the process for submitting postmarketing safety information on combination products. FDA commissioner Scott Gottlieb says the guidance “explains when a single, complete report can be used to meet multiple reporting requirements and what the
Drugs
A 9/4-9/8/17 FDA inspection at Malladi Drugs & Pharmaceuticals Limited, Chennai, India, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API), according to a 3/9 Warning Letter. Specific deviations cited in the letter were: * failing to use appropriate precautions to
Drugs
Researchers from Harvard, Yale, and Johns Hopkins universities say that facilitating patient access to drug manufacturers that had obtained approval from any of seven non-U.S. regulators (the European Union, Canada, Australia, New Zealand, Switzerland, South Africa, and Israel) could help sustain affordable access to essential off-patent drugs.
FDA Policy/General
MarketWatch says some drug companies are cautioning that co-pay accumulators, a new initiative involving coupons to lower co-pay on some medications, pose a financial risk to the companies. The online report says the new programs don’t let drug company coupons reduce a patient’s co-pay as
Drugs
The Massachusetts Supreme Judicial Court says a man who alleged he was injured after taking a generic form of Merck’s Proscar (finasteride) for benign prostatic hyperplasia may amend one portion of his complaint, while the other two elements were dismissed. The court’s opinion says a plaintiff may not
Devices
FDA has cleared a Restoration Robotics 510(k) to expand its Artas hair restoration technology to include robotic implantation. The company says the device is the first physician-assisted system to dissect, and assist in the harvesting of, follicular units directly from the scalp and create recipient implant sites using
Drugs
FDA has accepted for priority review a Pfizer and Astellas Pharma supplemental NDA for Xtandi (enzalutamide) for an expanded indication to include men with non-metastatic castration-resistant prostate cancer (CRPC). The submission is based on data from the Phase 3 PROSPER trial. The agency has set a user fee
Devices
Exactech has received 510(k) clearance to market Novation XLE Vitamin E acetabular polyethylene liners for hip replacement surgery. The liners are designed to work in conjunction with the Novation Crown Cup Acetabular System including InteGrip printed, 3-D porous material. The device features “advanced bearing material” for low wear
Drugs
As part of the Trump Administration’s opioid crisis plan, the president 3/19 warned pharmaceutical companies marketing opioid and other addictive pain killers that the Department of Justice is “looking very seriously into bringing major litigation against some of these drug companies.” Speaking at an anti-opioid addiction event
Devices
An 8/16-8/25/17 FDA inspection at Vilex in Tennessee, McMinnville, TN, found Quality System Regulation violations in the firm’s work as a specification developer and relabeler/repacker and conducting limited manufacturing operations for its Class 1 and 2 orthopedic implants and tools. A just-released 1/
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Diamond Wipes International Chino, CA (3/7): FDA inspected the firm 5/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to establish written
Devices
FDA has cleared a Life Spine 510(k) for the Plateau-LO Insert and Rotate Spacer System and its use in micro-invasive lumbar interbody fusion procedures. The device is available in PEEK material and is offered in 7-degree and 12-degree lordosis and multiple footprint options. It also
FDA Policy/General
Federal Register notice: FDA has extended by 60 days the comment period on a 12/20/2017 Federal Register notice entitled “Drug Products Labeled as Homeopathic; Draft Guidance for Food and Drug Administration Staff and Industry.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance on how to determine the number of employees for purposes of a “small business” definition. FDA allows certain exemptions for entities considered a “small business.” To view the notice, click here.
FDA Policy/General
Amazon has hired former FDA chief health information officer Taha Kass-Hout, a sign that the online retailing behemoth may be challenging Google and its X Lab in the health technologies race, according to a CNBC report. Kass-Hout has been quietly brought on at Amazon to serve in a
FDA Policy/General
Federal Register notice: FDA has announced a 6/11-12 public workshop on “Pathways to Global Unity.” The workshop is intended to provide information about agency drug and device regulation to regulated industries. To view the notice, click here.