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Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft
…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…
CDRH’s Plan to De-risk the Medical Device Valley of Death
…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…
FDA Releases Report on Rare Diseases and Accelerating the Development of Therapies for Pediatric Rare Diseases
…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…
For the Love of Money: The Trump Administration’s Fiscal Year 2018 FDA Budget Plan
…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…
Days Go By* – Particularly When Responding to an FDA Inspection
…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…
Florida Proposes Plan to Import Drugs from Canada
…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,…
FDA’s Pre-Cert Program Enters its Testing Phase
…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:…
GAO Report Confirms the Obvious: Food Safety Has Been Driving the Bus at FDA’s FVM Program
…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”…
CMS Proposes to Require WAC Disclosure in TV Ads for Rx Drugs
…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…
FDA Flexes New Enforcement Muscle; Issues Warning Letter for Failure to Meet Required Postmarketing Study Milestone Dates
…“3-month pancreatic safety study in a diabetic rodent model treated with sitagliptin.” FDA documented the agreement in approval letters (here and here) with the following timetable: Final Protocol Submission: June…
Let’s Play a Game: What’s Missing from FDA’s Recent Approval Letter for Generic COPAXONE 40 mg/mL?
…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…
Companies Shipping Chemicals: “Know the One You’re Dancing With”
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…
A Wolf in Sheep’s Clothing: When the Failure to Obtain a 510(k) for a Modification May Be More Than a Regulatory Violation
…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…
DOJ Files Criminal Case Against Vascular Solutions, Inc. for Off-Label Device Promotion
…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…
Second Bill to Curb Underage Dextromethorphan Abuse Introduced in House
…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…