Regulatory

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.

The White House is looking to pay for some of its prime social and health initiatives by reducing outlays for prescription drugs, according to an announcement by President Biden.

All eyes are watching closely to see how well Viatris and Biocon Biologics’ Semglee, approved by FDA on July 28, competes with Sanofi’s well-established, long-acting insulin analog, Lantus.

Sweeping competition initiative drills in on cost reduction.

In response to continued criticism of FDA’s initiative to make promising new therapies available to seriously ill patients based on early clinical results, Richard Pazdur, director of FDA’s Oncology Center of Excellence, lashed out at the alarmists and urged continued support for this early access process.

FDA is on track this year to authorize a notable number of new molecular entities and important biotech therapies.

FDA acting commissioner Janet Woodcock has outlined FDA’s plan to “transition to standard operations” for U.S. inspections.

FDA acting commissioner Janet Woodcock has bowed to pressure and called on the HHS’s Office of the Inspector General to examine the review process for Biogen’s Alzheimer’s disease treatment, Aduhelm.

With small biotechs facing similar expectations as large pharma in drug safety and pharmacovigilance, despite less resources, identifying the key differences between US and EU requirements can help these companies craft a practical path to multi-region compliance.

White House backs big boost in funding for research, public health.

Pandemic forces pharma companies to work faster and smarter to meet hard deadlines.

The Center for Biologics Evaluation and Research’s top priority is to approve biologics license applications (BLAs) to address vaccine hesitancy, according to CBER director Peter Marks.

An updated version of legislation to modernize clinical research policies and FDA expedited approval pathways is circulating on Capitol Hill in anticipation of gaining approval in the coming year.

CDER launches an initiative to gain more efficient and transparent operations of its advisory panels. Jill Wechsler reports.

How pharma firms assess their readiness for IDMP (Identification of Medicinal Products) is important for meeting compliance requirements and ensuring they are prepared for the digital product information management future, writes Adnan Jamil.

FDA’s surprise decision this week to approve Biogen’s treatment for Alzheimer’s Disease has raised serious questions about the validity and value of the agency’s accelerated approval process.

Separate pushes for vaccine equity, legislation to lower drug costs.

The Biden administration has rolled out a broad initiative to promote domestic production of critical materials, including medicines and their ingredients.

Biden administration supports a notable increase in funding for public health and research as a lead priority for the coming year.

FDA’s Q12 standard, crafted by members of the ICH, aims to help manufacturers manage changes in chemistry, manufacturing and controls of marketed drugs and biologics to encourage continual improvement in biopharmaceutical production.

FDA expects to conduct only a small portion of scheduled facility visits this year due to continued limitations on travel imposed by the COVID-19 pandemic

Now regulatory review teams have found a way to accelerate their processes — processes not particularly suited to speed — without compromising quality, accuracy, or adherence to regulations, how can this pace be maintained as we emerge from the pandemic?

The drive for “vaccine equity” around the world is bolstering efforts to limit patent protections on innovative medicines and vaccines to combat the global pandemic.