Opinion &amp; analysis

FDA investigator insights: Device makers forget about the humans who use their products

Device makers often fail to consider what happens once their product is in a patient’s hands, says a seasoned U.S. FDA investigator. She identifies seven common human-factor–usability–problems. Learn what they are so you can enhance compliance and patient safety.

May 31, 2018

‘UKCA Mark’ To Replace CE Marking In UK Now, Or Eventually?

UK notified bodies would have had their conformity assessment roles temporarily withdrawn in the event of a no-deal Brexit, according to guidance issued in February. BBC said the guidance represented a plan “to replace the CE safety symbol on products in the event of a no-deal Brexit.” Is this actually the case? Find out what the UK Association of British HealthTech Industries (ABHI) had to say.

February 4, 2019

R&D Heads At GSK & AZ Say Key To Success Lies In Smart Risk Taking

What’s the secret to successfully transforming research and development innovation into drug launches? Taking risks, but doing so in a focused, smarter way, say the heads of Britain’s two largest pharma companies. Read more about the secrets to their success here.

November 15, 2018

ECHA’s Microplastic Ban Proposal Is ‘Brutally Misinformed’ – Cosmetics Europe

ECHA’s plan to ban the use of intentionally added microplastics in cosmetics is based on “a whole clutch of errors and misunderstandings,” according to Cosmetics Europe’s Director-General John Chave. Find out why the industry is worried about this ban–and why they consider it unfair. Gain insights into which solutions would satisfy the industry, and learn why biodegradable plastics–which represent a potential win-win for industry and environmental advocates–may not be viable.

February 19, 2019

EU Post-Market Clinical Follow Up: What Manufacturers Need To Know

Consultant Sarah Sorrell offers insights on the EU’s new medtech regulations that have introduced much more comprehensive post-market clinical follow-up requirements for device and diagnostics companies. Medtech interviewed her about what the requirements entail and problems with understanding them.

August 2, 2019

The Advantages Of Providing Access To Unlicensed Medicines

As pharma companies increasingly include access to unlicensed medicines as part of their commercialization game plans, new challenges – and opportunities – are born. In this informative article, In Vivo examines both the potential pitfalls and probable triumphs of incorporating unlicensed medicines into commercial strategies.

November 5, 2018

Repositioning Market Access: A Function Fit For Purpose In A New Era Of Costly Cures

Explore the findings of an October 2018 panel discussion of market analysts and market access specialists as they discuss the question: As new cures and treatments for patients develop, how does the conversation shift from delivering market access to products to focusing on patient access to progress?

November 28, 2018

Schakowsky’s Loaded Cosmetics Bill Described as ‘Floor, Not a Ceiling’ for States to Build On

The Safe Cosmetics and Personal Care Products Act reintroduced to the US House of Representatives calls for greater duties and resource demands on companies and the FDA than the proposed Personal Care Act in the Senate and allows room for states to impose more stringent regulations.

September 2, 2019

Four Rules For Being A Consistent US FDA Reviewer From Peter Stein

The US FDA Office of New Drugs is adopting a new, flatter structure under the leadership of Peter Stein, who issued remarks on the matter at Biopharma Conference IV. He used the platform to explain some of the changes to come, and offered advice for cutting down on inconsistencies in information issued from the agency to reviewers.

December 11, 2018

US Office Of New Drugs Revamp Taking Shape: More Review Divisions Coming, But Who Will Lead Them?

The U.S. FDA’s reorganization of its Office of New Drugs (OND) faces leadership challenges, thanks to recent departures. How will the FDA staff these new divisions? Learn more about the departures, gain insights into the agency’s options, and explore the implications for the industry.

May 1, 2018

You Work In The Pharmaceutical Industry; Here’s Why You Should Care About The Novartis Payments

Novartis AG’s involvement–however tangential–in the Donald Trump/Michael Cohen/Stormy Daniels scandal is just the latest incident to tarnish the pharmaceutical industry’s public image. Explore how negative public perception could accelerate the move to price controls–and why it’s an industry-wide problem.

May 9, 2018

US FDA’s Office Of New Drugs Reorganization Approved, But Not Happening Overnight

After more than two years of work, the US Food and Drug Administration is ready to formally begin its reorganization of the Office of New Drugs. Pink Sheet covers how this could cause signatory authority and other changes for sponsors with pending applications.

August 2, 2019

Novartis’ New Oncology CEO Liz Barrett Charts A Course, But It Will Require Jump-Starting New Brands

Novartis Oncology CEO and newcomer to the company, Liz Bennett, sat down with Scrip ad talked about her plans for an organization currently in transition, and her strategy for moving new blockbusters forward. Access her insights into the future of Novartis Oncology in this illuminating interview.

June 6, 2018