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…approval and administrative actions can and should pay more to support FDA’s continued capacity. The Fiscal Year 2018 Budget includes $5.1 billion in total resources for FDA, which, with the…
…here, here, and here). In January of this year, FDA released version 1.0 of Developing a Software Precertification Program: A Working Model (Working Model) and an accompanying Software Precertification Program:…
…studies and other clinical trials for investigational drugs in PRD population Device strategies Develop expedited approval pathway for certain devices intended to treat unmet medical needs Evaluate the results of…
…scope of the TAP Pilot. Id. All in all, we think the TAP Pilot has the potential to be a valuable program and we applaud the Agency for including performance…
…Care Administration (AHCA) to establish a Canadian Prescription Drug Importation Program and an International Prescription Drug Importation Program. Florida Governor Ron DeSantis signed the bill into law on June 12,…
…is relatively straightforward. Any advertisement on TV (including broadcast, cable, streaming, or satellite) for a prescription drug or biological would have to contain the following statement: The list price for…
…all of the FVM Program’s strategic objectives. In addition, GAO notes that the Strategic Plan as yet lacks an implementation plan that would lay out “specific actions, priorities, and milestones”…
…15 business days to address. Regardless of whether the company can complete activities by the time the initial 483 response is due, or simply sets forth its plan for how…
…agrees the review can be achieved in real-time) De Novo 510(k): Traditional and Abbreviated Unfortunately, the final guidance continues to exclude Special 510(k)s (see our prior blog post here). In…
…example, FDA may conclude the paragraph with “You have also notified the Agency that the cases have been dismissed,” or with “this litigation is ongoing,” or with “Although these litigations…
…Second, on the civil side, Pfizer has agreed to pay $1 billion in civil settlements of cases which were brought under the federal False Claims Act (“FCA”) by whistleblowers (called…
Drug Enforcement Administration (“DEA”) civil monetary settlements involving listed chemicals that do not include pseudoephedrine are rare. Even more scarce are DEA civil settlements with non-registrants. (By my count there…
…civil allegations related to the same conduct under the False Claims Act. In light of the above approach to civil and criminal matters, companies now need to consider not only…
…forum shopping starkly contrasts with “the old days” when FDA criminal cases were almost always brought in the company’s principal place of business. This trend is troubling for companies because…
…the sale of dextromethorphan to individuals under 18 years old. Senator Robert Casey (D-Pennsylvania) introduced a companion bill, S. 644, the Preventing Abuse of Cough Treatment Acts of 2013, (also…