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In the News Articles and Insights

In the News: May 2021 Regulatory and Development Updates

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Approval of the Month: Non-Opioid for Post-Surgical Pain Gets FDA Nod Heron Therapeutic received FDA approval for its

In the News: April 2021 Regulatory and Development Updates

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA’s Accelerated Approval Program Comes Under Fire The public’s faith in drugs approved under the FDA’s accelerated approval

In the News: March 2021 Regulatory and Development Updates

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Rare Disease Clinical Trials Most Often Terminated Due to Regulatory and Recruitment Issues The difficulty associated with successfully

In the News: February 2021 Regulatory and Development Updates

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA: Sponsors Seldom Disclose RTF Letters’ Existence or Contents and Often Ignore Agency Advice The FDA revealed that

In the News: January 2021 Regulatory and Development Updates

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Approval of the Month: Previously Approved Oncology Drug Cleared for Rare Pediatric Indication Pfizer’s Xalkori (crizotinib) was approved

In the News: December 2020 Regulatory and Development Updates

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA Issues Advice on Combination Products In December, the FDA published “Requesting FDA Feedback on Combination Products” to

In the News: November 2020 Regulatory and Development Updates

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Remote Document Review Leads to CRL: Be Careful What You Wish for? The FDA’s halt of onsite inspections

In the News: October 2020 Regulatory and Development Updates

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning When the FDA requires a product’s labeling

In the News: September 2020 Regulatory and Development Updates

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA Establishes Digital Health Center of Excellence The FDA announced the launch of its Digital Health Center of

In the News: August 2020 Regulatory and Development Updates

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Fitbit developing algorithm for early detection of COVID-19 Fitbit recently posted a study that may indicate the company’s

In the News: July 2020 Regulatory and Development Updates

Each month, Camargo’s “In the News” series will highlight important changes and advancements in the regulatory and development space and explore how those changes could impact your program. FDA announces intention to resume domestic inspections Camargo recently examined an FDA Complete Response Letter which required