Drugs
FDA has sent Pain Therapeutics a third complete response letter (CRL) on its NDA resubmission for Remoxy ER (oxycodone capsules), asking for “additional actions and data” before considering approval again. The letter focuses on the drug’s abuse-deterrent properties and proposed drug labeling, according to the company, adding that
Devices
Pharmaceutical Research and Manufacturers of America (PhRMA) has filed an amicus brief supporting a request by CCS Medical Supplies that a Massachusetts federal court certify an anti-kickback law decision for interlocutory appeal. The case involves whistleblowers’ claims that CCS, which markets ostomy and continence care products, engaged in “illegal
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Ajes Pharmaceuticals, LLC. Copiague, NY (9/09). FDA inspected the firm’s dietary supplement facility and found serious GMP violations. For example, the firm failed to establish product specifications
FDA Policy/General
A recent 2nd Circuit Court of Appeals decision in a false advertising case explains the distinction between an advertisement that is literally false by implication and one that is impliedly false. Attorney Sandra Edelman (Dorsey & Whitney) writes in an online blog post that the decision involved a suit brought
Drugs
A 4/18-4/22 FDA inspection at Cheng Fong Chemical Co., Taoyuan City, China, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients (API). A 9/15 Warning Letter says the deviations included: * failing to have an adequate maintenance procedure to prevent contamination or carry-over
Drugs
A 1/5-2/2 FDA inspection of Elite Laboratories, Northvale, NJ, found serious violations of the Postmarketing Adverse Drug Experience (PADE) reporting requirements, according to a just-released 9/25 Warning Letter from the agency’s New Jersey District Office. Specifically, the letter says, the firm failed to develop
Drugs
FDA and the European Medicines Agency (EMA) are establishing a joint cluster on rare diseases to share scientific evaluation of various aspects of drug development for rare diseases. A document on terms of reference for the cluster says that the aspects include selection and validation of trial endpoints, potential trial
FDA Policy/General
Federal Register Notice: FDA has corrected a 9/19 notice entitled "A List of Biomarkers Used as Outcomes in Development of FDA-Approved New Molecular Entities and New Biological Therapeutics (10/2007 to 12/2015).” The notice established a docket to receive suggestions, recommendations, and comments from interested parties
Drugs
Janssen Research & Development has submitted a supplemental NDA for Imbruvica (ibrutinib) for treating patients with marginal zone lymphoma (MZL) who require systemic therapy. The filing is based on data from an open-label Phase 2 trial called PCYC-1121 that evaluated the therapy in MZL patients who have received
FDA Policy/General
Federal Register Notice: FDA has announced a public meeting to discuss proposed recommendations for reauthorizing the Generic Drug User Fee Amendments of 2012. The legislative authority expires 9/30/2017. The public meeting will be held 10/21 at FDA’s White Oak campus (Silver Spring, MD). To view this
Devices
FDA has cleared a Roche 510(k) for the Roche Syphilis treponemal antibody test, a fully automated assay for detecting antibodies to Treponema pallidium for use on all Roche immunoassay systems for low-, mid- and high-volume testing environments (including the cobas e 411, cobas e 601, cobas e 602
FDA Policy/General
FDA associate deputy commissioner for medical products and tobacco Rachel Sherman has been promoted to deputy commissioner for medical products and tobacco, which was commissioner Robert Califf’s position before being confirmed as the agency head in February. Sherman had retired from the agency in 2014 and subsequently joined Greenleaf
Drugs
After an FDA Office of Criminal Investigations probe, federal prosecutors have charged a Hoover, AL man with receiving and reselling misbranded male enhancement drugs from China that could cause serious side effects in men taking medications containing nitrates. Nabil Chagri has been charged with one count of receiving and selling
Drugs
U.S. senator Tom Cotton (R-AK) has introduced the Safely Advancing Valuable and Inexpensive New Generic Solutions Act, a bill that would require FDA to expedite the review process for both the first and the second introduced generic competitors to a brand name drug. The agency would also be
Drugs
FDA has approved a Janssen Biotech BLA for Stelara (ustekinumab) for treating moderately to severely active Crohn’s disease in adults (18 years or older) who have failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis factor blocker, or who failed
Drugs
Eisai Inc. has submitted a supplemental NDA for Fycompa (perampanel) seeking monotherapy use for treating partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older. Currently, the drug is approved as an add-on therapy in combination with another antiepileptic drug.
Biologics
In approving an Amgen biosimilar for the first copy of Abbott’s Humira (adalimumab) for multiple inflammatory diseases (see story), FDA also simultaneously denied an Abbott petition that sought to block the action by arguing such approval would violate the U.S. Constitution’s Takings Clause. The petition argued that
Drugs
GENERAL Comments Extended on Advisory Committee Appearances Guide Federal Register Notice: FDA has extended the comment period until 11/26 for a guidance on “Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees.” The extension is being granted due to errors displayed on the FDA
FDA Policy/General
BIOLOGICS FDA has approved Amgen’s Amjevita, a biosimilar copy of Abbott’s Humira (adalimumab) for multiple inflammatory diseases. This is FDA’s fourth approved biosimilar. DEVICES FDA has approved a Med-El USA PMA for the Synchrony EAS (Electric Acoustic Stimulation) Hearing Implant System. The device combines two technologies
FDA Policy/General
AstraZeneca has withdrawn a marketing application filed with the European Medicines Agency (EMA) for ovarian cancer drug cediranib and its use in combination with platinum-based chemotherapy followed by maintenance monotherapy to treat adult patients with platinum-sensitive relapsed ovarian cancer. EMA reportedly had concerns about whether the drug’s
Devices
Rep. Mike Fitzpatrick (R-PA) and several other members of Congress have written a letter to the House Energy and Commerce Committee asking for a hearing to investigate FDA’s “failings” over medical device safety. Fitzpatrick has been a vocal critic of the agency’s handling of laparoscopic power morcellators
FDA Policy/General
Federal Register Notice: FDA has extended the comment period until 11/26 for a guidance on “Procedures for Evaluating Appearance Issues and Granting Authorizations for Participation in FDA Advisory Committees.” The extension is being granted due to errors displayed on the FDA Web site pertaining to this guidance. To view