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FDA Proposes Generic Drug User Fee System and Performance Goals
…draft goals letter also includes a Regulatory Science Plan with several items of interest. In FY 2013, FDA would address bioequivalence of local acting orally inhaled drug products, local acting…
FDA Largely Denies Citizen Petition on Single, Shared REMS System, But Outlines Agency Standards and Processes
…require that a REMS “include such elements as are necessary to assure safe use of the drug, because of its inherent toxicity or potential harmfulness.” The Elements To Assure Safe…
OIG Report Calls Into Question Effectiveness of FDA’s REMS Program
…risks. REMS include medication guides, patient package inserts, communications plans, and, for drugs with the most serious risks, elements to assure safe use (“ETASUs”). ETASUs may include restricted distribution plans,…
Move Over, Cricket! Lickets: Edible Insects are On the March
By Ricardo Carvajal – People have been eating insects for thousands of years, and the practice certainly has its devotees in the U.S. Notwithstanding that history of consumption, industrial production…
Not In Our Backyard! Pharmacists and Trade Groups Sue to Block Implementation of Maine Drug Importation Law
By Kurt R. Karst – Earlier this week, the Pharmaceutical Research and Manufacturers of America (“PhRMA”), along with several other trade groups – the Maine Pharmacy Association, Maine Society of…
Eisai Says FDA Erroneously Triggered NCE Exclusivity Start Dates Before DEA Controlled Substance Scheduling Permitted Marketing
…when FDA commented that “[a] requirement in the approval letter for submission (but not for approval) of final printed labeling or other material that may delay the actual initiation of…
The Hackers are Coming!
…to intentional and unintentional cybersecurity risks associated with the device; A “traceability matrix” linking the actual cybersecurity controls to the cybersecurity risks considered; Plan for providing validated updates and patches…
CDRH Issues Draft Guidance for IDE and Pre-IDE Processes
…an IDE, FDA takes one of the following three actions: approval, approval with conditions (traditionally referred to as “conditional approval”), or disapproval. The draft guidance focuses primarily on the second of…
AMA Tells Pharmacists: “Don’t Call Us We’ll Call You”
…Intrusion into Medical Practice, received May 15, 2013. Delegations from New England have put forth an almost identical resolution to the AMA House of Delegates that also, while noting the regulations…
FDA Issues Guidance Regarding Contract Manufacturing Quality Agreements
…by the owner and those changes that require only notification. Although industry organizations, such as the International Pharmaceutical Excipients Council (“IPEC”) and the Active Pharmaceutical Ingredients Committee (APIC) of the…
FDA Commissioner Calls for More Active FDA Regulation of Laboratory-Developed Tests, and ACLA Promptly Responds with a Petition Opposing FDA
…tests are rapidly becoming a staple of medical decision-making, particularly for cancer. And some people with a family history of cancer are using these tests to decide whether to take…
The Medical Device Amendments of 1976: The Statute That Went Awry
…performance standards to one of several optional “special controls” for Class II devices. All of the device types placed in Class III were supposed to be subject to a prompt…
Are All Health and Wellness Mobile Apps Exempt from FDA Regulatory Requirements?
…doctor, nurse, nutritional advisor, a personal trainer, or friends in a support network. Other apps can assist users establish wellness plans to manage chronic conditions like asthma, heart disease, Crohn’s…
Will New Recommendations From NIH Curb Use of the Animal Efficacy Rule?
…in humans. Evaluation of the drug or biological product for safety in humans is still required, and cannot be addressed by animal studies alone. In addition, approval under the Animal…
From the Bleacher Seats: Amici Weigh in for the FTC in ANDROGEL Drug Patent Settlement Agreement Supreme Court Case
…came out in support of federal legislation to “end the practice of pay for delay in prescription medicine.” Knowledge Ecology International (“KEI”). KEI, which is an international non-profit, non-governmental organization…