John Robinson's Blog – April 2018 Archive (7)

That pharmaceutical companies need to hire professionals with the requisite qualifications is beyond question. This is not only required for the smooth conduct of activities in their course of their day-to-day work, but also because the FDA has set out its requirements for the proper educational and skill set qualification of employees in this profession in 21 CFR 211.25(a).

This FDA section underlines the need for educational qualifications, training and experience to carry out their…

digital payment industry could be thrown into disarray due to the demand by the Reserve Bank of India (RBI) that all user data be stored within the country, fears an industry grouping, which has termed the decision as “heavy-handed”, even as others, including the country’s largest digital payment provider Paytm, have hailed the move.

In a bid to narrow the growing schism, the industry is planning to send a formal…

Immune therapy drugs can transform lung cancer treatment, giving patients years of extra life, doctors reported Monday.

They found that pre-treating lung cancer patients with immune therapy drugs before they have surgery can help melt away the tumor and at the same time limit or even stop its spread.

And combinations of immunotherapy drugs have helped other lung cancer patients get off more toxic standard chemotherapy while also extending their lives.

The results are so…

FDA consulting services are those services that are offered by independent, mostly private companies in helping to meet FDA requirements. FDA consulting services are offered to organizations that have to meet FDA regulatory requirements. Many companies across the US and many other parts of the world specialize in offering FDA consulting services and these are often the main business for these…

One of the chief aims of the FDA is to ensure the protection of public health and making sure that select types of organizations comply with the provisions of the Food, Drug and Cosmetic Act. It enforces these aims by conducting periodic inspections of the facilities and types of organizations that come under its purview. The FDA is empowered by the terms of the Federal Food, Drug, and Cosmetic Act, Sec. 704…

A medical device has to mandatorily make a submission for premarket approval (PMA) to the FDA to demonstrate that the device to be marketed is substantially equivalent or at least as safe and effective as a non PMA-subjected legally marketed device. This submission is called 510 (K).

A medical device company has to submit a product for PMA when it manufactures or makes changes and modifications that could substantially affect safety and effectiveness requirements under 21 CFR 807 and…

PharmAbcine Inc., a clinical-stage biotech company developing novel antibody therapeutics for multiple cancer indications, announced today that U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its leading clinical compound TTAC-0001 for “treatment of Glioblastoma Multiforme.”

“We are very pleased with this Orphan Drug Designation from FDA for TTAC-0001 for GBM treatment since we have been preparing for clinical studies of TTAC-0001 plus KEYTRUDA®…