Biologics
CBER has released a list of 12 guidance documents in three categories it plans to publish during the 2018 calendar year. The document says the list includes topics that currently have no guidance associated with them, topics where updated guidance may be helpful, and topics for which CBER has already
Devices
FDA says that based on studies conducted by Becton Dickinson (BD), it continues to recommend that Magellan Diagnostics lead tests not be used with blood samples taken from the vein. A statement by CDRH Office of In Vitro Diagnostics and Radiological Health acting director Donald St. Pierre says that Magellan’
FDA Policy/General
The House and Senate 3/22 passed a fiscal year 2018 omnibus budget bill that will increase FDA’s budget authority (BA) by $41 million (1.5%) over FY 2017. The Alliance for a Stronger FDA welcomed the increase, noting that any boost to FDA’s bottom line is a
Drugs
FDA has cleared an Orthofix International 510(k) for its new internal fixation system, the G-Beam Fusion Beaming System, intended for use in treating Charcot foot, a debilitating condition where the bones in the foot weaken and collapse. The device is designed to be implanted in the medial and
Devices
FDA says it is aware from medical device reports of 414 cases of breast-implant associated anaplastic large cell lymphoma (BIA-ALCL) as of 9/30/17, including the death of nine patients. The new figure is in an agency online update on BIA-ALCL and agency recommendations for healthcare
Drugs
Attorney Mark Schwartz (Hyman, Phelps & McNamara) says in an online post in his firm’s FDA Law Blog that the FDA quality metrics reporting program first announced in 2015 now appears to be on hold. Although the agency had said in 11/2016 that it intended to open an
Drugs
FDA has approved a Sun Pharmaceutical Industries NDA for Ilumya (tildrakizumab-asmn) for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The drug selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor, which
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Postmarketing Safety Reporting for Combination Products.” The draft guidance addresses certain means by which applicants may comply with the 12/2016 final rule on postmarketing safety reporting requirements for combination products. To view the notice, click here.
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