Featured Pharma Online Editorial

51. What To Do When Your Regulatory Findings Need Quality Risk Management Action 10/2/2024

    More than half of all recent warning letters issued by the FDA include citations for absent or incomplete risk assessments. This article examines what regulators are looking for.

52. EMA Issues Draft Guideline On The Development And Manufacture Of Oligonucleotides 9/26/2024

    The EMA recently issued a draft guidance, Guideline on the Development and Manufacture of Oligonucleotides. It includes requirements and considerations related to conjugation, active substance in solution, and more. The consultation period ends Jan. 31, 2025.

53. FDA Issues Revised Guidance On Controlling Nitrosamine Impurities In Pharmaceuticals 9/11/2024

    The FDA has issued a revised version of its guidance, Control of Nitrosamine Impurities in Human Drugs. This article explores the agency's recommendations, root causes of nitrosamines, and strategies for mitigating their presence in pharmaceuticals.

54. EMA Issues New Draft Guideline: Chemistry Of Active Substances 9/3/2024

    The European Medicines Agency (EMA) has issued a new draft guideline to set out the type of information required for the manufacture and control of active substances used in a medicinal product. The public consultation period ends Jan. 31, 2025.

55. FDA Issues Draft Guidance On Use-Related Risk Analysis (URRA) 8/14/2024

    The FDA released a new draft guidance, "Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products," in July. The public comment period closes on Sept. 9, 2024.

56. DSCSA Implementation Is Progressing, But More Complexity May Be Coming 8/5/2024

    The FDA recently announced it would exempt small dispensers from requirements of the Drug Supply Chain Security Act (DSCSA) until Nov. 27, 2026. The industry has made tremendous progress so far with DSCSA, but this discretion will make compliance more challenging.

57. The Learned Intermediary Doctrine Sees Curious Change In California 8/5/2024

    U.S. courts have long recognized the learned intermediary doctrine, which holds that a manufacturer of a prescription medication or medical device discharges its duty to warn by providing an adequate warning to the doctor. In the recent Himes v. Somatics, LLC, the California Supreme Court may have opened the door to this argument. 

58. 2023–2024 Trends In FDA Form 483s For Pharmaceutical Formulation Facilities 8/1/2024

    A comprehensive review of FDA observations from small molecule drug facilities sheds light on the state of compliance and regulatory practices in the pharma industry.

59. FDA Finalizes Guidance About Delaying, Denying, Limiting, Or Refusing An Inspection 7/25/2024

    The FDA has finalized a guidance on the circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. The agency also provides reasons that may cause drugs or devices to be adulterated under the FD&C Act.

60. Making Good Decisions When FDA Investigators Come Knocking 7/18/2024

    Ready or not, when the FDA inspector arrives, the test has already started. New final guidance makes clear what the agency considers an attempt to stonewall.