Regulatory Pharma Blogs
New Drug Application (NDA) & Requirements crucial document to submit USFDA New Drug Application For many decades, the regulation and oversight of new drugs in the United States have centered around the New Drug Application (NDA). Since 1938, every new pharmaceutical intended for U.S. commercialization has required an approved NDA. The NDA serves as the …
Investigational New Drug (IND) approval processes and time-lines involved. Investigational New Drug Current federal law mandates that a drug must have an approved marketing application before it can be transported or distributed across state lines. When sponsors intend to ship an investigational drug to clinical investigators in multiple states, they must seek an exemption from …
Regulatory Approval Process for Investigational New Drug (NDA-24) Investigational New Drug Background Investigational New Drug Investigational New Drug The drug approval process involves a regulatory pathway through which individuals, organizations, sponsors, or innovators obtain permission to introduce a drug into the market. This process typically includes several stages: applying for clinical trial authorization, conducting clinical …
New Drug Discovery and developments-Pharmaceutical regulatory affairs-2024 New Drug Discovery and developments Drug discovery is a complex and multi-step process that involves identifying chemical compounds for potential therapeutic use in treating and managing various diseases. This process encompasses the identification of drug candidates, synthesis, characterization, screening, and efficacy testing through various assays. Once a molecule …
loan license to obtain in India, medical device manufacturers must adhere to regulatory requirements. loan license in the context of medical devices involves an arrangement where a company without manufacturing capabilities can partner with another manufacturer possessing the necessary facilities. This agreement, sanctioned by the State Licensing Authority (SLA) or Central Licensing Authority (CLA), allows …
Curie.Bio Secures $380M in Series A Funding to Advance Biotech Startups to Clinical Stage Curie.Bio incubator has successfully secured $380 million for its latest fund, aimed at supporting startup companies as they progress toward clinical trials. Announced on Wednesday, this Series A fund raises Curie.Bio’s total funds to almost $1 billion. Founded in early 2023 …
Patent: How Pfizer, Bristol Myers Squibb, and Johnson & Johnson Are Addressing Patent 2024 Expirations Patent: The pharmaceutical industry is confronting a significant patent cliff, with the potential loss of hundreds of billions in sales as more than 190 products are set to lose exclusivity between 2022 and 2030. This isn\’t the first time the …
5 Key FDA Decisions to Keep an Eye on in the Latter Half of 2024 5 Key FDA Decisions :This year has been notable for numerous significant FDA approvals. These include the first tumor-infiltrating lymphocytes (TIL) therapy, the first gene therapy for a rare pediatric condition, and the initial targeted treatment for MASH, marking 2024 …
Dr. Yusuf Hamied: How an Indian Entrepreneur Challenged Big Pharma to Offer AIDS Medications at $1 a Day Dr. Yusuf Hamied of Cipla was an avid reader of medical journals, spending over $150,000 annually on subscriptions (equivalent to 1 crore rupees today). In 1986, he encountered something entirely new to him. A colleague remarked, “The …
Regulatory affairs in clinical research are vital, ensuring trials comply with rules for patient safety and effective treatments. Introduction to Regulatory Affairs in Clinical Research Regulatory affairs are crucial for guaranteeing pharmaceutical products and medical devices meet safety, effectiveness, and quality standards. In clinical research, professionals in this field ensure adherence to regulations set by …