Regulatory

31. Final Guidance Locks In FDA's Definitions For Suspect And Illegitimate Drug Product 4/7/2023

    With a Drug Supply Chain Security Act deadline looming, FDA published its final guidance clarifying terms the agency uses to describe illegitimate and suspect drug product.

32. Avoid Launch Delays By Planning For An FDA-Required REMS 4/3/2023

    If you don't account for the time and effort necessary to develop, implement, and operate a REMS, you could be significantly impacting launch timing and patient access.

33. New EU Directive Marks Cybersecurity Regulatory Paradigm Shift 4/3/2023

    There is a regulatory paradigm shift underway to protect digital assets and data. But, few laboratories, CROs and CDMOs, and pharmaceutical and medical device manufacturers can meet the NIS2 cybersecurity requirements today.

34. How Biopharmas Can Navigate Data Privacy Laws And Unlock Value 4/3/2023

    It should be no surprise that data privacy and responsibility is emerging as a high-priority target for life sciences companies, driven by regulatory compliance and market differentiation.

35. A Regulator Looks Back On What We Learned From Accelerated SARS-CoV-2 Neutralizing mAbs Development 3/29/2023

    Prior knowledge, platforms, parallel backup programs, and strategic timing all come into play when rapidly scaling up a mAbs development program in response to a public health emergency.

36. Draft FDA Labeling Guidance Proposes More Clarity For Providers 3/7/2023

    The FDA's draft guidance for prescription and biologic drugs updates a 2010 guidance and comes following the boom of activity in the biologics space. This article breaks down and analyzes the update on labeling for prescription drugs and biologics on an increasingly complex landscape. 

37. Circumstances For Delaying, Denying, Limiting, Or Refusing An FDA Inspection 3/1/2023

    Delaying, denying, limiting, or refusing a drug or device inspection without a reasonable justification will result in a less than collegial atmosphere during an FDA inspection.

38. Trends In FDA FY2022 Inspection-Based Warning Letters 2/21/2023

    We analyzed the warning letters that the FDA issued to pharmaceutical and biotech companies in FY2022. Several key trends emerged, including a heightened scrutiny on two product types.

39. 2023's Market Outlook For Cell And Gene Therapies 2/14/2023

    This article discusses quantifiable market trends, clinical developments, regulatory landscape analysis, and investment trends for cell and gene therapy companies in 2023.

40. Persistent Noncompliance Leads To A Consent Decree 2/1/2023

    What happens when failures are discovered repeatedly during FDA inspections, even after the company has been warned to correct them?