Featured Articles

41. Right-To-Try Or Right-to-Ask? Understanding Right-To-Try And FDA's Expanded Access Programs 8/5/2019

    Programs providing seriously ill patients with early access to investigational products are of great interest to the public, but what are the implications to pharmaceutical and biotechnology product companies? This article examines Right-to-Try legislation as well as FDA’s existing expanded access programs from the perspective of companies who are considering providing investigational products to patients with serious or life threatening diseases that have exhausted all other treatment options.

42. Master Protocols And The New FDA Guidance 8/5/2019

    In September of 2018, FDA released a new FDA guidance on master protocols. So, what are master protocols, how can they benefit sponsors and patients, and what are the challenges?

43. Accelerating Regulatory Product Development And Approval For Drugs And Biologics In The U.S. 8/5/2019

    The Food and Drug Administration (FDA) has created five mechanisms to presumably speed the approval of drugs and biologics that effectively treat serious diseases, especially those that are the first of their kind or those that provide increased benefit over existing treatments. Following is an overview on how to appropriately use these five programs to maximize speed of approval depending on the product type.

44. Seven Essentials For Successful Drug Development 8/5/2019

    In reflecting on the differences between successful and unsuccessful clinical trials or programs, several factors consistently emerge as essential components of success and failure. This article reminds of the essentials so that effective therapies have a greater likelihood of reaching patients in need.

45. 505 (b)(2) vs. ANDA: How Complex Drugs Fit In 2/7/2019

    Read how recently released draft guidance documents can provide clarity on abbreviated approval pathways and highlight priorities of the FDA to increase competition in the marketplace with a focus on speeding generic approvals, including complex generic drug products.

46. Cellular Therapy Studies: 7 Common Challenges 8/1/2018

    Cellular therapy is a form of treatment where patients are injected with cellular material. Different types of cells can be utilized such as stem cells (such as mesenchymal stem cells) and cells from the immune system (such as regulatory T cells (Tregs)) from either the patient or a donor.

47. Implementing Patient-Centric Principles in Asthma Research 3/21/2018

    Change the perception of clinical trials by making them less burdensome for patients overall.

48. 10-Step Commercial Clinical Protocol Authoring Guide 9/13/2017

    Before the protocol authoring process even begins, a variety of activities and decisions are necessary to establish a strategy for success. The following steps provide concepts and considerations that are essential in formulating the details that will become the protocol synopsis and ultimately the clinical study protocol.

49. FDA Expectations For Diversity Inclusion In Clinical Research 5/24/2017

    The trend toward increasing the diversity of clinical trial participants is encouraging, but a continued effort is needed to keep moving in the right direction.

50. FDA Guidance On Non-Inferiority Clinical Trials To Establish Effectiveness 5/24/2017

    In November 2016 the FDA released final guidance on Non-Inferiority Clinical Trials to Establish Effectiveness providing researchers guidance on when to use non-inferiority trials to demonstrate effectiveness along with how to choose the non-inferiority margin, test the non-inferiority hypothesis, and provide interpretable results. The guidance does not provide recommendations for how to evaluate the safety of a drug using a non-inferiority trial design. This article provides background on a non-inferiority trial design along with assumptions and advantages and disadvantages of the trial design.