Group items tagged

"The global carbon black market size is projected to reach USD 25.95 billion by 2025 expanding at a CAGR of 6.0%. Increasing tire production on accounted of growing transportation industry is driving the product demand. Carbon black is a highly regulated industry as the manufacturing process is considered harmful owing to the toxic emissions, which have adverse effects on the environment and health. In February 2003, it was added to the California Office of Environmental Health Hazard Assessment (OEHHA) list of substances known to the State that cause cancer. Major companies in the market are focusing on R&D activities to develop new manufacturing techniques to reduce harmful emissions. Stringent regulations to curb emissions are expected to play a major role in driving the market growth. Emerging countries in Asia Pacific, such as China, Thailand, India, and Indonesia, are projected to generate the maximum product demand in the coming years. Manufacturers in North America and Europe regions are forced to shift their operations to Asian countries owing to low cost in emerging countries. However, recovery in the automotive industry in countries, such as Germany and France, is are anticipated to boost market growth in Europe over the forecast period."

Learn about various product approval processes, product development and regulatory filing strategies focusing on 505(b)(2) pathway.

In this session the instructor will discuss about the pediatric drug development study and the regulations that support this initiative.

"The global emulsion polymers market size is expected to reach USD 60.37 billion by 2025. It is projected to expand at CAGR of 6.3% over the forecast period. Increasing construction spending, particularly in Asia Pacific and Middle East, has prompted the demand for paints and coatings in the recent past. Growth of paints and coatings industry has had a direct impact on the demand for emulsion polymer. Stringent environmental regulations to control noxious chemical emissions coupled with increasing preference for greener products are expected to limit synthetic based demand and augment bio-based and water based products. Volatile prices of key raw materials are expected to remain a key challenge for market participants over the forecast period. Growth of the key end-use industries, including paints and coatings and adhesives, is expected to drive the market. However, volatility in the prices of primary raw materials is expected to restrain the growth."

Several medical devices use either off-the-shelf or custom software. A couple of guidance documents from FDA written almost a decade ago are the only official comments from FDA to assist manufacturers understand the current FDA requirements. Despite a long history of software usages in medical devices, there is significant confusion regarding updating software applications in new 510(k) devices and the additional testing requirements. The level of details expected in a 510(k) application is very different from what used to be 10 years ago. This webinar will discuss the structure and level of detail required in filing a 510(k) when a medical device is software or contains software.

Attend this webinar to learn about when you require a premarket approval for a medical device and FDA approval process for medical devices.