The onset of the coronavirus, or COVID-19, created havoc across the globe since its emergence in December 2019 in Wuhan, China, and fast spreading potential. Though no longer considered a “public health emergency” (under section 319 of the Public Health Services Act), the virus and its new strains are still actively circulating. This requires rigorous […]
Assessing COVID-19 Symptoms in Clinical Trials Read More »
In the realm of healthcare, patients have a fundamental right to transparency and information regarding the procedures they undergo particularly with respect to medical devices used for surgical procedures. One often overlooks the aspect of this right which is the traceability labels for medical devices used in surgical procedures regardless of whether the device is
Asserting Patient Rights: The Importance of Labels for Medical Device Traceability Read More »
Regulatory authorities across the globe play a pivotal role in safeguarding patient safety and ensure regulatory compliance. Each authority functions in its unique way to uphold standards and ultimately ensure the well-being of individuals. In the UK, the MHRA shoulders the vital responsibility of ensuring that medicines, medical devices, blood components for transfusion are safe, of
Importance of Collaboration between Global Regulators Read More »
DDReg is thrilled to announce a significant milestone that is the establishment of its new entity in Cologne (Köln), Germany. This strategic development marks a pivotal moment for DDReg in expanding & enhancing its global presence and reflects DDReg’s commitment to better serve its customers in their requirements for/in the European market. DDReg is confident
DDReg Opens German Entity in Cologne (Köln) Read More »
Regulatory scrutiny for abbreviated new drug applications (ANDAs) places a strong focus on the accuracy and completeness of ANDA labels. Not only does this provide comprehensive information to healthcare professionals, but it also communicates information on medication usage and potential risks to ensure patients get clear and detailed information. This meticulous review process highlights the
Submitting Revised ANDA Labels to Ensure Safety & Compliance Read More »
Chimeric antigen receptor (CAR) T cell products refer to therapeutic human gene therapy products. They involve the genetic modification of T cell specificity which allows them to recognize a specific target antigen for therapeutic use. CAR T cells are associated with many challenges related to their development, manufacturing, testing, and even clinical evaluation. Therefore, it
Development of CAR T Cell Products Read More »
Timely patient access to affordable treatment options is the goal of healthcare and regulatory agencies worldwide. To support this, early and frequent communication between drug applicants and regulatory agencies is required to expedite generic drug development and approval. Streamlined communication allows a better and clearer understanding of regulatory expectations and facilitates a more efficient application
Model-Integrated Evidence Program for Generic Drugs Read More »
Product-specific bioequivalence guidelines are crucial to support the development of safe, efficacious, and high-quality generic products. They provide information to manufacturers on how they can demonstrate therapeutic equivalence of their products compared to the reference drugs. Adherence to these guidelines streamline the regulatory approval process while also ensuring confidence with respect to the interchangeability of
Searchable Databases for Bio-Equivalence Guidance Read More »
The field of gene therapy has witnessed significant advancements with the development of genome editing technologies. These technologies allow scientists to break, modify, and edit specific genes in a DNA sequence-specific manner, opening up new possibilities for gene therapy. While traditional gene therapy involves the addition of new genes to human cells or tissue, genome
The Advancements of Gene Editing Technology for Safe and Effective Gene Therapy Products Read More »
Customer Requirement: A pharmaceutical company specializing in generic products, based in Saudi Arabia, required a customized additional risk minimization measure (aRMM) for its generic version of Pomaliomide capsules. This was a requirement of the regulatory agency, the Saudi Food and Drug Authority, in order to maintain safety and regulatory compliance. Problem Statement: The National Pharmacovigilance
Customized aRMM for National PV Center in Saudi Arabia Read More »
