Expert Analysis

• 10 Practical Takeaways From FDA's Biopharma AI Guidance

  

  Recent guidance from the U.S. Food and Drug Administration provides much-needed insight on the usage of artificial intelligence in producing information to support regulatory decision-making regarding drug safety, with implications ranging from life cycle maintenance to AI tool acquisition, say attorneys at Covington.

• Opinion

  We Must Allow Judges To Use Their Independent Judgment

  

  As two recent cases show, the ability of judges to access their independent judgment crucially enables courts to exercise the discretion needed to reach the right outcome based on the unique facts within the law, says John Siffert at Lankler Siffert & Wohl.

• How Health Cos. Can Navigate Data Security Regulation Limbo

  

  Despite the Trump administration's freeze on proposed updates to the Health Insurance Portability and Accountability Act security rule, there are critical cybersecurity steps healthcare organizations can take now without clear federal guidance, says William Li at Axiom.

• Series

  Performing Stand-Up Comedy Makes Me A Better Lawyer

  

  Whether I’m delivering a punchline on stage or a closing argument in court, balancing stand-up comedy performances and my legal career has demonstrated that the keys to success in both endeavors include reading the room, landing the right timing and making an impact, says attorney Rebecca Palmer.

• Lawmakers Shouldn't Overlook Rare Disease Therapies' Value

  

  As the ORPHAN Cures Act is pending in Congress, policymakers assessing the value of certain drugs for price regulation should consider data beyond what is collected in clinical trials, say Alice Chen at the University of Southern California, and Molly Frean and Yao Lu at Analysis Group.

• Series

  Adapting To Private Practice: From SEC To BigLaw

  

  As I adjusted to the multifaceted workflow of a BigLaw firm after leaving the U.S. Securities and Exchange Commission, working side by side with new colleagues on complex matters proved the fastest way to build a deep rapport and demonstrate my value, says Jennifer Lee at Jenner & Block.

• Making The Case For Rest In The Legal Profession

  

  For too long, a culture of overwork has plagued the legal profession, but research shows that attorneys need rest to perform optimally and sustainably, so legal organizations and individuals must implement strategies that allow for restoration, says Marissa Alert at MDA Wellness, Carol Ross-Burnett at CRB Global, and Denise Robinson at The Still Center.

• What Trump's Order Means For The Legal Status Of IVF

  

  An executive order signed by President Donald Trump last month signals the administration's potential intention to increase protections for in vitro fertilization services, though more concrete actions would be needed to resolve the current uncertainty around IVF access or bring about a binding legal change, says Jeanne Vance at Weintraub Tobin.

• Mitigating Tariff Risks For Healthcare In US And Canada

  

  Healthcare stakeholders should take steps to evaluate the impact of cross-border tariffs, as the historically strong ties between Canada and the U.S. demonstrate the potential for real disruption and harm to the healthcare industry in both countries, say attorneys at Norton Rose.

• 4 Ways Women Attorneys Can Build A Legal Legacy

  

  This Women’s History Month, women attorneys should consider what small, day-to-day actions they can take to help leave a lasting impact for future generations, even if it means mentoring one person or taking 10 minutes to make a plan, says Jackie Prester, a former shareholder at Baker Donelson.

• Bid Protest Spotlight: Prejudice, Injunctions, New Regulations

  

  In this month's bid protest roundup, Markus Speidel at MoFo looks at three recent decisions that consider whether a past performance evaluation needs to show prejudice to be successfully challenged, the prerequisites for injunctive relief and the application of new regulatory requirements to indefinite-delivery, indefinite-quantity contracts.

• A Judge's Pointers For Adding Spice To Dry Legal Writing

  

  U.S. District Judge Fred Biery shares a few key lessons about how to go against the grain of the legal writing tradition by adding color to bland judicial opinions, such as by telling a human story and injecting literary devices where possible.

• What Advisory On Alcohol And Cancer May Mean For Cos.

  

  While the federal government has yet to take concrete steps in response to a January advisory from the outgoing U.S. surgeon general on links between alcohol consumption and cancer, the statement has opened the door to potential regulatory, legislative and litigation challenges for the alcoholic beverage industry, say attorneys at Mayer Brown.

• What's At Stake In High Court Transgender Care Suit

  

  The outcome of U.S. v. Skrmetti will have critical implications for the rights of transgender youth and their access to gender-affirming care, and will likely affect other areas of law and policy involving transgender individuals, including education, employment, healthcare and civil rights, say attorneys at ArentFox Schiff.

• 6th Circ. Ruling Paves Path Out Of Loper Bright 'Twilight Zone'

  

  The U.S. Supreme Court’s Loper Bright ruling created a twilight zone between express statutory delegations that trigger agency deference and implicit ones that do not, but the Sixth Circuit’s recent ruling in Moctezuma-Reyes v. Garland crafted a two-part test for resolving cases within this gray area, say attorneys at Wiley.