Regulatory

Scott Swain details the most common roadblocks that pharma companies experience when incorporating real-world data (RWD) in regulatory submissions and looks at how they can be addressed.

In a highly unusual decision for a therapy approved by FDA, CMS has taken action to limit prescribing and use of Biogen’s new and controversial Alzheimer’s treatment Aduhelm.

Progress in 2022 will require nimble action across several fronts.

As the pressure on teams reviewing promotional content has increases, both in terms of volumes of content and complexity, Sameer Lal discusses the need for a near-term strategies using artificial intelligence (AI) and machine learning (ML) to decongest bottlenecks of the manual review process.

Despite major challenges and demands created by the coronovirus pandemic, FDA maintained a steady pace in 2021 in approving important new therapies for market.

FDA has become embroiled in the debate over access to “chemical” or “medication” abortions through the prescribing and distribution of the abortifacient, mifepristone.

The Biden administration’s choice to lead FDA successfully navigated a Senate confirmation hearing on Dec. 14, setting the stage for full Senate approval early next year.

For biopharma innovation to succeed and accelerate, companies must stop duplicating their efforts and share valuable information.

Lack of IP management plagues recent regulatory discussions.

COVID vaccine development highlights need for modernization.

Practices to ensure accuracy in selected datasets.

New gene therapies for debilitating rare conditions stand to advance from an FDA collaboration with the National Institutes of Health and a cadre of pharma companies, small biotechs and patient groups.

The 2013 Drug Supply Chain Security Act (DSCSA) established a framework for exchanging data when products are transacted throughout the US pharma supply chain. Its goal, by November 2023, is to enable unit-level traceability in a secure, interoperable manner. HDA’s Chip Davis talks about how pharma manufacturers must prepare for this implementation deadline.

Leading legislators have launched the campaign to enact a second version of the 21st Century Cures Act.

The Identification of Medicinal Products (IDMP) software industry has talked up the broader potential of data-driven processes. Pharma companies and their software providers have an important role to play in realizing these processes. Frits Stulp discusses the foundations that need to be laid for lasting transformation of pharma information access in the real world.

The White House nominates Robert Califf to once again take the reins of FDA, but acting commissioner Janet Woodcock will remain in place during the Senate confirmation process.

FDA is seeking to address the added complexities for incorporating real-world data and real-world evidence into submissions to the agency, while addressing concerns about its relevance and reliability.

FDA is expanding its Emerging Technology Program (ETP) and providing more support for new drug applications (NDAs) that present advanced manufacturing technologies, but the agency and industry face key challenges in advancing these initiatives.

Word is out that the White House will name cardiologist and research pro Robert Califf to the top FDA job, a position he held for almost a year at the end of the Obama administration. But he may face opposition in the Senate.

Changes prompt collaboration and improved quality management.

Demand for more efficient and faster development of medical products is prompting regulatory authorities to incorporate additional sources of information into research and approval processes.

Critics say FDA is either acting too fast and risking public safety—or too slow, mired in rules while ignoring important scientific findings.

The stars finally may be aligned for Americans to gain greater access to alternative biotech therapies in the coming months.

If the debate over vaccines for adults and the need for extra booster shots has been heated, FDA will face even more scrutiny over the safety and value of vaccinating children under age 12.

FDA’s Vaccines and Related Biological Products Advisory Committee announces its recommendations for the authorization of a third dose of the Pfizer/BioNTech Comirnaty vaccine.

But accelerated approval program faces scrutiny.

FDA is launching a program to test the safety and suitability of novel inactive ingredients for use in new drugs and biologics.

FDA has revealed its plan for revising and renewing its fee program for drugs and biologics.

With large M&A deals comes a complex Market Authorization Transfer (MAT) process, during which regulatory teams must weigh several operational aspects while creating a roadmap that takes them into account. Cecile Riboud outlines some key questions that are necessary for planning and executing a successful MAT process.

While biopharma companies will pay more than $3 million to file an NDA or BLA application during fiscal year 2022, new fees for generic drugs will see modest or no increases and those for biosimilars may drop or hold even.