| | The FDA is engaged in numerous activities to protect and promote public health during the COVID-19 pandemic. For CDER, these efforts include accelerating development of treatments for COVID-19, maintaining and securing drug supply chains, providing guidance to stakeholders, advising developers on how to handle clinical trial issues, and keeping the public informed. Information on some of CDER's efforts related specifically to drugs and COVID-19 can be found here in the 2020 issues of the newsletter. Recent updates are provided below: | | SPOTLIGHT ON CDER SCIENCE | | FDA's approval of Veklury (remdesivir) for the treatment of COVID-19—The Evidence for Safety and Effectiveness in November 2020  Veklury became the first drug approved by FDA as a treatment for COVID-19 in adults and pediatric patients (12 years of age and older and weighing at least 40 kg) requiring hospitalization in October 2020. The scientific evidence from the Adaptive COVID-19 Treatment Trial (ACTT-1) trial, combined with FDA's assessment of the SIMPLE trials, supported the determination that the standard for substantial evidence of effectiveness and demonstration of safety as required for a new drug approval were met and that the benefit of treatment with Veklury included a shorter time to recovery and better odds of clinical improvement. Learn more. | | | REGULATORY SCIENCE IMPACT STORIES | | | CDER is continuing to highlight its regulatory science research in a series of regulatory science impact stories. Recent posts include:  Using Artificial Neural Networks to Predict Drug Response Pharmacokinetic (PK) models of drug exposure and pharmacodynamic (PD) models of drug response help us predict how drugs will affect the highly diverse patients that need them. Applying concepts from deep learning, CDER researchers constructed a type of artificial neural network that is especially suited to sequential pharmacologic data. When trained on simulated data from a traditional PK/PD model for a set of patients on once-daily drug regimens, this neural network learned to predict PD response even when the drug dosing regimen was changed. The researchers comment on how complimentary use of deep learning and traditional modeling approaches may help us to better predict drug responses in patients. Learn more. |  How computational analysis of a 3D mucociliary clearance model can help predict drug uptake and lead to more generic nasal drug products In 2020, CDER's Office of Generic Drugs (OGD) and several partner researchers quantified the effect of drug solubility and partition coefficient on the dissolution and subsequent uptake of drugs in a realistic nasal cavity model. Complex locally acting generic drug products, such as some orally inhaled or nasal drug products, can be more challenging for generic drug developers to copy, often leading to a lack of generic competition even after patents and exclusivities no longer block generic drug approval. Accurate and realistic predictions from computer simulations about deposition and absorption of nasally inhaled drugs can provide a deeper understanding of complex fluid-particle dynamics in the nasal cavity which may help OGD clarify regulatory expectations early in the drug development process and during application assessment. Learn more. | | | | Recent Scientific Publications by FDA/CDER Staff can be found here .
Some examples are provided below:  Conveying risk in direct-to-consumer drug ads CDER's pilot study suggests that "framing statements" containing information on the severity of possible adverse effects may help consumers make more informed decisions about the product's risks. Learn more. |  FDA modernizes the review of NDAs The testing, implementation, and rationale of the new Integrated Assessment process and Integrated Review document are explained by CDER reviewers. Learn more. |  Reducing impurities during solid phase synthesis of nucleic acid-based drugs As therapeutics consisting of DNA or RNA show increasing promise, CDER researchers have found a way to decrease potentially harmful impurities generated during the synthesis of these molecules. Learn more. |  A Bayesian approach in pediatric cancer clinical trials CDER statisticians show how Bayesian approaches can be used to design, monitor, and analyze pediatric trials. Learn more. |  Screening FDA-approved drugs against multiple targets of SARS-CoV-2 CDER researchers working with external collaborators present a novel strategy for in-silico molecular modeling screening for potential drugs that may interact with proteins of SARS-CoV-2. Learn more. | | | | For more information, please visit the FDA In Brief Webpage. Scientific Internships and Fellowships / Trainees and Non-U.S. Citizens Whether you're an undergraduate looking to pursue a career in science, a graduate student seeking experience in regulatory science, a postgraduate looking for fellowship opportunities, or a senior scientist pursuing research experience in your field of expertise, FDA offers you many paths to learning about the exciting field of regulatory science. Click here for more information. | | | | |
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