…review of a small business certification request within 60 calendar days of receipt. If granted, the company can enjoy the benefits for that fiscal year alone, which runs from October…

…design of proof-of-concept or other pilot safety/biodistribution studies necessary to support a FIH trial General recommendations about a future FIH trial where the population is novel and there is no…

…caused us, who work in the medical product industry, to wonder how the federal government officially declares an end to the Covid-19 public health emergency. Before we talk about the…

…§ 220(e)(2). “Laboratory” is defined broadly as “a facility for the biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body…

…administration, planned duration of treatment, monitoring procedures, and planned modifications to the treatment plan in the event of toxicity. A letter of authorization from the investigational drug’s manufacturer Information about…

…plans (“QHPs”) and other programs related to health insurance exchanges under Title I of the Affordable Care Act (“ACA”) are not “Federal health care programs” for purposes of the Federal…

…require for all extended-release opioid medications.  The final REMS was issued as part of the White House’s multi-agency plan to reduce prescription drug abuse.  FDA has been working on a…

…during a May 11th speech at the Sixth Annual In-House Counsel Forum on Pharmaceutical Antitrust, and again during a May 18th speech titled “The Intersection of Antitrust and Intellectual Property:…

…treatment claims are also live and subject to judicial review, because, among other things, they are capable of repetition with other allegedly grandfathered products the companies manufacture and distribute (e.g.,…

…to enhance compliance capability by implementing its “business-case-for-quality” (in 2011 this was referred to as “Case for Quality”), though the sub-goals are different.  In 2011, this goal was to be…

…products: (1) a National Critical Drug List; and (2) a National Critical Drug Shortage List.  The bill does not actually define the terms “critical drug” or “critical drug shortage.”  Rather,…

…conditions to support a different context of use. Validation can additionally be provided by population-based evidence, emergent model behavior, model plausibility and model calibration evidence. Model calibration evidence is an…

…[FDA’s] communication plan to inform and educate health care providers, patients, and payors on the benefits and risks of medical products, with particular focus on underrepresented subpopulations, including racial subgroups.”…

…and contingency planning.  It also looked at key potential unintentional and intentional threats to the active implantable medical devices.  The unintentional threats are defective software and firmware and interference caused…

…restricted distribution program but not an ETASU REMS – ZAVESCA (miglustat) Capsules – filed counterclaims alleging that Actelion abused its monopoly power in violation of Sections 1 and 2 of…