Regulatory Affairs Editorial

  1. Employing GMP Techniques In GCP For More Robust, Compliant Clinical Studies

    Most of my career has been on the good manufacturing practices (GMP) side of industry, where, despite moments of ambiguity or confusion, everything is presented in black-and-white terms. And over the last five years or so, I have had the pleasure of supporting and/or overseeing the good clinical practice (GCP) side of industry, experiencing the more “human” side of the business.

  2. Extrapolation Trials Provide Hope To Epilepsy Patients

    The concept of extrapolation has been in existence for years at the FDA. Lynn Kramer, MD, Chief Clinical Officer and Chief Medical Officer of the Neurology Business Group at Eisai, is excited about the current use of extrapolation in monotherapies. The FDA approval of FYCOMPA as a monotherapy for epilepsy patients was based on data extrapolation. 

  3. 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?

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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?

  9. Doctors And Researchers Attempt To Stop Right-To-Try Legislation

    A group of academics who work at the intersection of drug development and medical ethics are jumping into the kerfuffle over proposed Right To Try (RTT) legislation, noting they are deeply concerned about the ramifications of a federal RTT law for patients and families. In a letter to the leadership of the House of Representatives’ Energy and Commerce Committee health subcommittee, the group notes it has “strong opposition’ to the pending legislation.

  10. Designing Clinical Studies To Avoid Regulatory Scrutiny

    Earlier this year, the Department of Justice (DOJ) announced a $3.5 million settlement against Primex Clinical Laboratories, a California laboratory providing clinical diagnostic testing services. As if that multimillion-dollar fine was not ominous enough, the DOJ announced another settlement in the same press release: It had imposed a $270,000 fine against the CEO of a related pharmacogenetics testing facility. The alleged wrongdoing centered on “sham” clinical trials, purportedly designed to mask improper payments to physicians who ordered pharmacogenetics tests.