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…Continue
Added by Adam Fleming on April 19, 2018 at 7:25am — No Comments
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…Continue
Added by Adam Fleming on April 17, 2018 at 7:47am — No Comments
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…Continue
Added by Adam Fleming on April 12, 2018 at 6:46am — No Comments
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…Continue
Added by Adam Fleming on April 10, 2018 at 7:07am — No Comments
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…Continue
Added by Adam Fleming on April 5, 2018 at 7:00am — No Comments
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®…Continue
Added by Adam Fleming on April 2, 2018 at 7:29am — No Comments
Regulatory Affairs sit at the center of an industry like pharmaceuticals. Given the importance this industry and the products its manufactures have on the health of human beings; it is imperative that there should be regulations in the industry at every stage of the process of manufacturing and marketing of pharmaceuticals.
Added by Adam Fleming on March 26, 2018 at 6:54am — No Comments
Among the many offshoots of the growth of technology; virtual healthcare is a very recent and important development. In simple language, virtual healthcare, a term easy enough to understand, is the use of technologies that enable remote consultation and monitoring of healthcare.
Putting technologies to remote use has been in use for a while now, what with corporate entities carrying out conferences and virtual conferences at the push of a button. Virtual…
Added by Adam Fleming on March 22, 2018 at 7:34am — No Comments
Good Documentation Practices (GDP) is a quintessential part of regulated manufacturing and laboratory environments. GDP has to be adhered to in the regulated industries because it is the only truly authentic method of ensuring that documents are audited and accounted for. GDP is also essential to keep track of and maintain control at all stages of the process and the product. GDP is thus a core requirement of a thoroughly developed Quality System.…
Added by Adam Fleming on March 20, 2018 at 7:13am — No Comments
The late-night comic had found his perfect straight man. In June 2014, John Oliver sat down with renowned theoretical physicist Stephen W. Hawking for an interview.
“You’ve stated that there could be an infinite number of parallel universes,” the host of HBO’s “Last Week Tonight,” asked Hawking. “Does that mean there’s a universe out there where I am smarter than you?”
Added by Adam Fleming on March 14, 2018 at 7:23am — No Comments
The effectiveness of a pharmaceutical water system depends on its design. The design is the soul of the system. Any pharmaceutical water system design should come equipped with the ability to serve its most basic purpose, which is to help the pharmaceutical organization meet the set quality.
The importance of water can never be overemphasized. Apart from the emotional, spiritual and cultural value it has; water also enjoys a position of complete primacy in the…
Added by Adam Fleming on March 12, 2018 at 5:48am — No Comments
Suddenly. Beloved husband of Katherine and dear father of Mary, John and Kevin. Jerry had a long and personally rewarding career as a dedicated nurse, taking him into contact with many who truly appreciated his care. He will be sadly missed by his loving wife, sons, daughter, son-in-law Alan, daughter-in-law Grace, grandchildren Molly, Emma, Séan and Āine, brother Tommy, sister Betty, sisters-in-law, brothers-in-law, nephews, nieces, relatives, nursing colleagues, patients and many friends.…Continue
Added by Adam Fleming on March 7, 2018 at 5:22am — No Comments
If there is one common cause for apprehension between the smallest and biggest, and the best known and least known organizations; it has to be an FDA inspection! Any organization that is subject to an FDA inspection has to get absolutely everything of everything about its activities right to a T, to such an extent that it should be sure simply all the time, through all its processes, that an…
Added by Adam Fleming on March 1, 2018 at 6:16am — No Comments
All medical devices have their stated intended use. With time, many of them undergo changes with use. Because of this, they need to be calibrated to retain their effectiveness. The FDA’s medical device calibration requirements have been devised with the same intention.
Although the FDA has medical device calibration requirements, many of these medical devices do not have specific measures that need to be set. So, in view of this, the FDA can only require that the…
Added by Adam Fleming on February 27, 2018 at 4:58am — No Comments
Failure Mode and Effects Analysis (FMEA) is a core aspect of risk management and risk analysis in medical devices. FMEA is essentially about analyzing the reasons for which a problem arises and the effects it has on the system. In the field of medical devices, it is absolutely critical to understand the failure mode and effects because the consequences of not doing this can be…
Added by Adam Fleming on February 23, 2018 at 5:39am — No Comments
A hundred Stoneman Douglas High School students are busing 400 miles to Florida’s capital Tuesday to urge lawmakers to act to prevent a repeat of the massacre that killed 17 students and faculty last week.
The students plan to hold a rally Wednesday in hopes that it will put pressure on the state’s Republican-controlled Legislature to consider a sweeping package of gun-control laws, something some GOP lawmakers said Monday they would consider. Shortly after the shooting, several…Continue
Added by Adam Fleming on February 20, 2018 at 5:02am — No Comments
The FDA has regulations on medical device packaging design. This is quite natural, considering that the FDA has several regulations on all aspects of medical devices. However, it needs to be mentioned that the FDA regulation that covers medical device packaging design – Sec. 820.130 Device packaging under Subpart K–Labeling and Packaging Control -is a single liner, which only merely states that “each manufacturer shall ensure that…
Added by Adam Fleming on February 16, 2018 at 4:47am — No Comments
Process validation is one of the essential functions of a quality system for medical devices. Medical device manufacturers who have to stay compliant with regulatory requirements have to obtain premarket approvals (PMA), as well as premarket notifications for both new and modified existing medical devices. The key to all these is medical device process validation.
Added by Adam Fleming on February 14, 2018 at 5:04am — No Comments
Process validation for medical devices is a key ingredient of quality assurance in medical devices. Process validation is the criterion for measuring the effectiveness of a quality system for medical devices. The first step that medical device manufacturers have to take to show compliance with regulatory requirements for new and modified existing medical devices is obtaining premarket approvals (PMA) and premarket notifications. Process validation for medical devices is…
Added by Adam Fleming on February 6, 2018 at 5:10am — No Comments
When Omar F. Khawaja compiled his priority list for 2018, he didn’t include which security technologies he wanted or how many IT staff he hoped to hire.
Instead, the CISO at Highmark Health — a healthcare management and insurance provider whose portfolio includes Allegheny Health Network, United Concordia Dental and Visionworks, among others — articulated an overarching strategy on how the cybersecurity plan should fit within the national organization’s business…Continue
Added by Adam Fleming on February 2, 2018 at 5:06am — No Comments