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FDA Issues Final Guidance on “Labeling for Biosimilar Products”
  • Cozen O'Connor
  • USA
  • October 18 2018

The FDA’s final “Labeling for Biosimilar Products Guidance for Industry” (Final Guidelines) should be viewed as a clear effort to boost timely access


FDA Public Meeting on Tobacco Product Application Review
  • Troutman Sanders LLP
  • USA
  • October 18 2018

On October 22-23, 2018, the Food and Drug Administration will hold a public meeting on the tobacco product application review process. More


Medical Board of Australia v Hung Phan
  • MinterEllison
  • Australia
  • October 18 2018

A former medical practitioner, Dr Hung Phan engaged in professional misconduct after making 13,465 fraudulent Medicare claims totalling $834,188.20.


CMS Takes Steps to Bring Clarity to the Archaic Medicare Local Coverage Process; Additional Changes to Promote Coverage of Innovative Technologies in the Works
  • Reed Smith LLP
  • USA
  • October 18 2018

In an effort to “modernize the Medicare program and bring the latest technologies and innovations to Medicare beneficiaries,” CMS has announced


FDA Regional Incident Preparedness and Response Playbook Provides Guidance to the Healthcare Industry for Large-scale, Multi-patient Medical Device Cybersecurity Incidents
  • Baker & Hostetler LLP
  • USA
  • October 18 2018

Earlier this month, the Mitre Corporation, on behalf of the Food and Drug Administration (FDA), released the Medical Device Cybersecurity Regional


Will the FTC Match DOJ’s Efforts to Speed Up Merger Reviews?
  • Epstein Becker Green
  • USA
  • October 18 2018

On October 3, 2018, at a hearing before the U.S. Senate Subcommittee on Antitrust, Competition Policy, and Consumer Rights (“Hearing”), Makan Delrahim


New Laws Take Effect Jan. 1 for Healthcare Facilities in Illinois
  • Taft Stettinius & Hollister LLP
  • USA
  • October 18 2018

As the end of the year approaches, Illinois hospitals and health care facilities should prepare for new changes in the law, designed to address the


Transferring marketing authorizations as a result of Brexit: key tax considerations
  • Baker McKenzie
  • United Kingdom, European Union
  • October 18 2018

Developing, producing and marketing medicinal products involves a significant amount of regulation grounded in EU law for pharmaceutical companies to


The skilled machines disrupting drug design
  • Hogan Lovells
  • USA
  • October 18 2018

Capable of identifying novel compounds for therapeutic use, AI is saving time and costs in a process that can take around 10 to 15 years and billions


Strategies to Unlock AI's Potential in Health Care, Part 2: FDA’s Approach to Protecting Patients & Promoting Innovation
  • Mintz
  • USA
  • October 18 2018

Artificial intelligenceAIis the future of everything. But when patient health is on the line, can we trust algorithms to make decisions instead of