Regulatory Affairs Editorial

  1. Do New Standards Make It Easier To Involve Patients In Research?

    With over 7,000 medicines currently being developed, the future of medicine looks exciting, but there are still questions: How do we achieve this future, and do we really need more standards or regulations … or more freedom?

  2. Kazia Tries Adaptive Approach For Brain Cancer Trial

    Getting drugs to cross the blood-brain barrier can be a challenge for sponsor companies. Kazia Therapeutics is working on a treatment for glioblastoma, the most common and aggressive form of brain cancer. Kazia will use an adaptive approach in a Phase 2 trial using a product which was designed by Genentech to cross the blood-brain barrier.

  3. India Making Way For Separate Clinical Trials Rules

    The key law that governs the pharmaceutical industry in India is the Drugs and Cosmetics (D&C) Act, 1940 and Rules, 1945. Over time, several amendments have been made to the D&C Act and rules. Schedule Y and Part XA (which covers rules 122A, 122B, 122D, 122DA, 122DAB, 122DAC, 122DB, 122DC, 122DD, and 122E) describe the various procedures for importing or manufacturing new drugs for sale or undertaking clinical trials (CTs) in the country. The Central Drugs Standard Control Organization (CDSCO), the national regulatory agency (also known as the Central Licensing Authority), regulates CTs in India.

  4. Strategies For Effective Risk And Capability Assessments When Choosing A Clinical Provider

    Recent revisions to the International Council for Harmonisation (ICH) Guideline for Good Clinical Practice, as outlined in ICH E6 (R2), have provided an impetus for sponsors to reevaluate their oversight and quality management processes throughout the clinical development process.

  5. Speed, Cost, Or Quality In Clinical Trials — Don't Pick Two

    Many of you have no doubt heard someone in your current or past organization say, “Quality, cost, and speed — pick two.” This statement refers to the perception that a project cannot achieve all three areas as priorities and therefore the organization must choose which two out of the three to prioritize.

  6. RTT Legislation: Where Do We Go From Here?

    In what likely came as a surprise to many who were expecting congress to pass a federal Right-To-Try (RTT) bill, the legislation was defeated by a vote of 259-140. The next step forward for RTT legislation is unclear. Maybe it is time to put politics aside and focus on patients.

  7. Legal & Ethical Considerations For Informed Consent In Clinical Trials

    The purpose of this article is to provide some thoughts as to the role each of us can play in clarifying some issues related to informed consent. These perspectives are based on my experiences as a registered nurse in a career that spanned more than three decades in private hospital settings, a private surgical association, and a university health system.

  8. Can “Trial Shaming” Force Companies To Report Results?

    A large number of clinical trials performed by pharma companies and universities are still not having their results reported to in a timely manner. They are also still not being fined per FDAAA. Is shaming these companies into reporting their results the best way to get their attention?

  9. Are We Making Progress For Patients With Rare Diseases?

    A Q&A discussion around the progress we have made in combatting rare diseases with Douglas Fambrough, president and CEO of Dicerna Pharmaceuticals; Patrick McEnany, president and CEO of Catalyst Pharmaceuticals; and Emil Kakkis, president and CEO of Ultragenyx Pharmaceutical.

  10. Fear, Indecision, And The Memo To File

    How many times have you seen or heard this phrase? Perhaps it came in an email, echoed out of the conference room phone, or maybe you’ve even said it yourself?