The journey of a drug product doesn’t end with its post-market authorization. The drug’s performance is now openly evaluated by the general population. To safeguard the population against any undesirable outcomes, post the consumption of a drug, a pharmacovigilance alert system is in place.
- June 17, 2022 Pharmacovigilance, Pharmaceuticals, Regulatory Affairs
- June 15, 2022 Pharmaceuticals, Regulatory Affairs
Over the decades, advancements in treatment procedures have brought about necessary amendments to the Regulatory framework. From Active Pharmaceutical Ingredient (API) identification to its placement on the patient’s side table, the core of innovating novel treatment protocols revolves around three (03) fundamental characteristics, including safety, effectiveness, and timely availability to the patient population.
- June 14, 2022 Pharmaceuticals, Publishing & Submissions
Pharmaceutical companies incur about 25% of drug development costs into the documentation. Strategic imperatives can help accelerate the drug development pipeline along with scrutiny of clinical and Regulatory content, enabling efficient reuse of more standardized content. Identifying gaps associated with content authoring, review, and approval, describing set goals, and commencing a plan is a way to move forward.
- June 6, 2022 Medical Devices
The US is the largest medical device market, worth USD 180 billion (2021) and is expected to reach USD 670 billion at a CAGR of 5.2% from 2022 to 2027. The global medical device manufacturers find it promising to get their devices approved by US FDA and subsequently export them to the US.
- June 3, 2022 Pharmaceuticals, Publishing & Submissions
Over the past ten (10) years, the cost of bringing a drug into the market has increased by 140 percent. Globally, the top twenty (20) pharmaceutical organizations spend nearly sixty (60) billion dollars every year to bring a drug into the market and the average cost is estimated to be $2.6 billion, including drug failures.
- June 1, 2022 Pharmaceuticals
Unmet Medical Need (UMN) is one of the most pressing priorities of health systems. Constantly evolving science and technology around healthcare has harbored the potential to explore various therapeutic options. Health Authorities encourage innovative therapies that promise significant benefits to patients' quality of life.
- May 20, 2022 Publishing & Submissions, Health Authority Updates
Pharmaceutical advertising, including direct-to-consumer advertising, is regulated by the United States Food and Drug Administration’s (US FDA) Office of Prescription Drug Promotion (OPDP), Advertising and Promotional Labeling Branch (APLB) at the Center for Drug Evaluation and Research (CDER), and the Center for Biologics Evaluation and Research (CBER) respectively.
- May 19, 2022 Pharmacovigilance, Compliance, Audit and Validation, Regulatory Affairs
When the COVID-19 pandemic was first recognized as a global health crisis in 2020, global Health Authorities (HAs) took innovative steps to deal with it in the best possible manner. Likewise, pharmaceutical companies came up with several vaccines/medicinal products for the benefit of the public. However, registering the products turned out to be quite challenging.
- May 18, 2022 Food and Food Supplements, Regulatory Affairs
Food labeling claims in the USA can differ based on factors like types of claims, the product of interest, and usage. They are also different for animal food, human food, and dietary supplements. The regulations and scientific standards ensure the labeling claims for food and food supplements are mentioned correctly and substantiated scientifically.
- May 17, 2022 Compliance, Audit and Validation
In the wake of COVID-19, deploying remote audit techniques is rising in the Life Sciences industry. With the imposed travel restrictions across the globe, medical devices, biotech, pharmaceuticals, and other life sciences organizations are turning towards virtual or Remote audits. The remote audit is carried out by utilizing video conferencing auditor and auditee and other software/web applications.