DDReg pharma

Quailty Driven by Passion

Submit Query

Regulatory

Home » Blogs » Regulatory » Page 12

US FDA: Enhancing the safety of cosmetic products

Blogs, Regulatory /

In the ever-evolving landscape of personal care and aesthetics, cosmetic products have risen to prominence and have wielded significant influence over individual and societal perceptions of allure. Yet, the journey from development to commercialization is underpinned by a complex tapestry of regulations designed to ensure consumer safety, uphold product integrity, and govern industry practices. In […]

US FDA: Enhancing the safety of cosmetic products Read More »

Overcoming challenges in determining AI limits for NDSRIs

Blogs, Regulatory /

Introduction Nitrosamine Drug Substance-Related Impurities (NDSRIs) share structural similarity with API and are therefore unique to every APIs. Drug products containing API that have 2° or 3° amines, when mixed with excipients that have the ability to cause the nitrosation reaction, are responsible for the formation of NDSRIs. There is often a lack of mutagenicity

Overcoming challenges in determining AI limits for NDSRIs Read More »

The Impact of Artificial Intelligence in the Lifecycle of Medicines

Blogs, Pharmacovigilance, Regulatory /

The rapid digitalization of the biomedical and clinical research sectors has ushered in a new era of advancements, with artificial intelligence (AI) taking centre stage as a transformative solution. In particular, AI is revolutionizing drug discovery processes by harnessing the vast amount of data generated during molecule screening phases and preclinical studies. As a result,

The Impact of Artificial Intelligence in the Lifecycle of Medicines Read More »

Enhancing Accessibility to Contraceptives through Rx-to-OTC switch

Blogs, Regulatory /

In a world where women’s health and autonomy are of utmost importance, ensuring diverse and accessible contraceptive options has become a pressing priority. In response to evolving societal demands, the call for inclusive and non-prescriptive contraceptive solutions has emerged, allowing individuals to take control of their reproductive health, irrespective of their background or circumstances. The

Enhancing Accessibility to Contraceptives through Rx-to-OTC switch Read More »

The Future of Certificate of Suitability

Blogs, Pharmacovigilance, Regulatory /

The Certificate of Suitability (CEP) to the monographs of the European Pharmacopoeia (Ph. Eur.) plays a crucial role in verifying the quality standards of active pharmaceutical ingredients (APIs). Issued by the European Directorate for the Quality of Medicines (EDQM), the CEP serves as evidence that an API complies with the rigorous quality requirements outlined in

The Future of Certificate of Suitability Read More »

ICH: An Approach to Harmonizing Real World Data & Real World Evidence

Blogs, Regulatory /

The use of real-world data (RWD) and real-world evidence (RWE) in Life Sciences and Pharma is significantly gaining recognition for the value it brings in making enhanced regulatory decisions. The evaluation of pharmaceuticals throughout their development and lifecycle is a complex process that requires robust evidence to ensure their safety and effectiveness. Traditionally, randomized clinical

ICH: An Approach to Harmonizing Real World Data & Real World Evidence Read More »

US FDA: Resolving Disputes for Over-the-Counter Monograph Drugs

Blogs, Pharmacovigilance, Regulatory /

Over-The-Counter (OTC) monographs define the safety, effectiveness, and labelling of the active ingredients in OTCs. The US FDA released a guidance document that provides suggestions for industry and review staff on resolving scientific and medical disputes related to OTC monograph drugs. It describes the Center for Drug Evaluation and Research (CDER) formal dispute resolution (FDR)

US FDA: Resolving Disputes for Over-the-Counter Monograph Drugs Read More »

US FDA: Safety Reporting Requirements for Combination Products

Blogs, Pharmacovigilance, Regulatory /

In this new era, where different therapeutic realms converge, the emergence of combination products has revolutionized the healthcare landscape by providing more innovative treatment options to treat the unmet medical needs of patients. However, with great power comes great responsibility. Continuously monitoring these products and ensuring they are safe to use is paramount in order

US FDA: Safety Reporting Requirements for Combination Products Read More »

Challenges in Complex Generic Drug Development

Blogs, Pharmacovigilance, Regulatory /

Complex drugs add more value to patients compared to simple generics as they are capable of addressing unmet needs of patients for particular conditions. However, biopharmaceutical companies encounter distinctive hurdles when it comes to the advancement of complex generic drugs. These medications, known for their intricate characteristics or the requirement of additional clinical trials, necessitate

Challenges in Complex Generic Drug Development Read More »