…long been incorporated in medical devices and subject to traditional regulation (Software In A Medical Device, or SIMD). And early iterations of software as a medical device (SAMD) fared reasonably…

…Policy, Planning, Legislation and Analysis, took questions on the new policy in a conference call. Mr. Zeller emphasized that although nicotine itself is not associated with negative health consequences, the…

…to determine if the change can be submitted as a Special 510(k). The Special 510(k) Program Guidance provides an example of a change involving the addition of wireless control capabilities…

By Allyson B. Mullen – For the past several years, a public-private stakeholder Planning Board has been evaluating the possibility of a new National Medical Device Evaluation System (NMDES). See our…

…FDA regulations governing the conduct of clinical trials.  The program also verifies the accuracy and reliability of clinical trial data submitted to FDA in support of research or marketing applications….

…approved drugs for on-label indications and also off-label indications that are supported in recognized compendia or supported by clinical evidence reported in medical literature.  OIG will conduct a new study…

…a written animal food safety plan, conducting a hazard analysis and implementing risk-based preventive controls, if needed. The draft guidance includes five chapters: food safety plan requirements; recommendations for conducting…

…fewer than 10 initial subjects) when this information cannot practically be provided through additional nonclinical assessments or appropriate nonclinical tests are unavailable.  Information obtained from an early feasibility study may…

…(D.N.J. June 3, 2013) (opposition to partial motion to dismiss). The BMS and Merck opinions are already affecting pending cases that raise similar allegations.  In another case with similar allegations…

…care practitioner for an initial diagnosis and an initial prescription.  Some patients who obtain an initial prescription do not continue on necessary medication because they would need to make additional…

…outweigh its risks.  Under FDAAA, a REMS can include a Med Guide, elements to ensure safe use (“ETASU”), such as limits on distribution, and a communication plan to HCPs.  Despite…

…to “approval” in FDC Act FDC Act § 505(q)(1)(G) means that “section 505(j)(5)(D)(i)(IV) also applies when the first applicant is eligible for a final approval, but not for a tentative…

…seek a partial or total shutdown of the allegedly offending defendant until it can come into compliance with applicable legal requirements. In addition, the standard FDA Consent Decree (and litigated…

…trials[; and] – to aim at global pediatric development plans based on scientific grounds, and compatible for both Agencies. Also, under a revised Implementation Plan for the Confidentiality Arrangement, FDA…

Last June, we blogged about a lawsuit brought by the Pharmaceutical Research and Manufacturers of America (PhRMA) challenging CMS’s ill-conceived Accumulator Adjustment Rule (“final rule”), which amended the Medicaid Rebate…