Administrative

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Below are links to key pleadings and other documents related to United States v. Cohen, in which Michael Cohen, the President’s former private lawyer, pleaded guilty to willfully causing an unlawful corporate contribution and making an excessive contribution to the President’s campaign. Also below are links to some of the key court documents in United States v. Edwards, in which John Edwards, the former U.S. senator and presidential candidate, was acquitted on a charge that…
In this episode, hosts Jason Crawford and Mana Lombardo speak with Trina Fairley Barlow, a partner in the firm’s Labor and Employment and Government Contracts groups, and Christine Hawes, counsel in the Labor & Employment Group, to discuss the False Claims Act’s retaliation provision and considerations for investigating FCA allegations brought by whistleblowers. “Let’s Talk FCA” is Crowell & Moring’s podcast covering the latest developments with the False Claims Act. Listen: Crowell.com | PodBean |…
Introduction The EMA has published a draft Guideline on clinical investigation of recombinant and human plasma-derived factor IX products.[1] The purpose of this guideline is to provide applicants and regulators with harmonised requirements for applications for marketing authorisation of haemophilia B medicinal products. In July, a similar guideline was adopted concerning haemophilia A medicinal products. The draft describes data that needs to be collected during clinical trials for a haemophilia B medicinal product prior…
As seen on: ROI-NJ.com By Tom Bergeron The city of Newark has one of the top locations in the country for investors looking to take advantage of the new Opportunity Zone Program, according to a national study released Thursday morning. The LOCUS National Opportunity Zone Ranking Report ranked a census tract in downtown Newark in a tie for sixth place among the top Opportunity Zones for Smart Growth Potential, in a ranking of nearly 8,000…
Notwithstanding the fact that a draft deal has been agreed between the EU and the UK at a technical level, the developments of recent days and weeks have made it clear that significant obstacles will need to be overcome before any deal can be finalised and ratified. In light of this uncertainty, there remains a very real possibility that the UK could leave the European Union without a deal in place on 29 March 2019…
On Tuesday, December 4, the Federal Trade Commission (FTC) announced that it had submitted a comment regarding the Food and Drug Administration’s (FDA) revised draft guidance on citizen petitions. This is the latest public step by the agency to highlight its continued close scrutiny of potential abuses of the citizen petition process to block or slow the entry of would-be competitors into pharmaceutical markets. Although substantively the FTC’s comment does not provide new guidance as…
On 11 December 2018 the Dutch Senate approved the bill for the establishment of the Netherlands Commercial Court (NCC). The NCC is a separate chamber of the District Court of Amsterdam, specializing in complex international commercial disputes. Proceedings before the NCC will be conducted in English, and judgments will be rendered in English. The NCC offers internationally operating companies the opportunity to conduct proceedings in the Netherlands before a specialized Dutch Court in the…
Pharma-Biotech_Conveyor Belt of Bottles
Earlier today, FDA published its finalized Data Integrity Guidance.  The Final Guidance is entitled “Data Integrity and Compliance With Drug CGMP: Questions and Answers,” and updates the agency’s April 2016 Draft Guidance covering the design, operation, and monitoring of systems and controls to maintain data integrity to comply with current good manufacturing practice (cGMP) for drugs.  The Final Guidance says that in recent years, FDA has “increasingly observed cGMP violations involving data integrity” during inspections,…