Regulatory

Graham Francis sets out 5 critical business drivers for building a global enterprise labelling strategy over the year ahead.

A NASEM report stresses the importance of information sharing by biopharma companies and cooperation among regulatory authorities.

2019 saw progress towards ISO Identification of Medicinal Products data standards implementation, but making patients front and central to project focus must remain a priority, says Frits Stulp.

Developers of biosimilars have become dismayed with difficulties in gaining acceptance and reimbursement from the US healthcare system.

CDER's Rare Disease Cures Accelerator initiative looks to foster a coordinated research approach and methods that can expedite development of drugs to treat some of the 7,000 rare diseases.

A new drug shortages report from FDA revives the call for a rating system to help drug purchasers, hospital buying groups and consumers identify quality products that warrant higher prices. Jill Wechsler reports.

Coexisting with the DSCSA may hinder new legislative efforts.

Lapse spotlights wider actions to ensure data accuracy.

The Center for Drug Evaluation and Research has finally gained approval for broad changes in its process and procedures for evaluating and approving new drugs.

Time is running out on Ned Sharpless’ term as FDA acting commissioner, generating much talk as the administration shows interest in naming a new head for the agency.

Market consolidation limits sales, while legal challenges offset regulatory gains.

As part of the legislation expanding the federal Open Payments program, drug and medical device manufacturers will have to report payments and other “transfers of value” to a broader range of health professionals.

Jill Wechsler casts her eye over the multitude of health reform measures emerging on Capitol Hill.

It is worth keeping patients, clinicians, pharmacists and the wider public front of mind when evaluating priorities and best next steps towards Identification of Medicinal Products(IMDP) and other emerging standards, writes Frits Stulp.

Every big shift will stir up dissenters, but these negative forces can actually offer a useful contribution if their concerns are fed into a continuous change program. This could make all the difference in regulatory information management transformation, writes Steve Gens.

In a sit-down with editors from our group publications, former FDA Commissioner Scott Gottlieb chatted with Pharm Exec on several topics, including the evolution of pricing and reimbursement for novel therapies-and the access fixes needed for future.

Ben Jacoby assesses the scope for disruption of the significant changes in medical device transparency and traceability requirements, and advises on a practical response.

Advice for developers in steering gene therapies from concept to trials to hopeful approval in what is an uniquely complex path.

HHS, FDA back Trump back cheaper foreign drugs to cut pharma costs. Jill Wechsler reports.

Agency focused on advancing testing and production methods, seeking input from other regions on common approaches.

In their latest article summarizing efforts to put each of the “American Patients First” blueprint's four strategies into action, Rick Kelly and Nisha Desai focus on the Lowering Out of Pocket (OOP) Costs strategy.

How R&D organizations can leverage FDA’s final guidance on pre-approval information exchange (PIE) to engage with payers prior to approval and launch.

What to make of the simmering public and political angst

New guidances open the door to interchangeables and less costly insulin.

In the third in a series of articles summarizing efforts to put each of the “American Patients First” blueprint's four strategies into action, Rick Kelly and Nisha Desai focus on “Incentivizing Lower List Prices.”

R&D organizations can leverage FDA’s final guidance on pre-approval information exchange, otherwise known as PIE, to engage with payers prior to regulatory approval and commercial launch.

A provision in a Senate health reform bill has reignited debate over the whether biological products should have to meet product quality standards established by the U.S. Pharmacopeia.

Congress is weighing in on drug pricing with a range of measures that differ in style and substance.

Cell and gene therapies in crosshairs of pricing focus, prompting stepped-up proposals on ways to finance these products.

Sabina Heinz and Elizabeth Baynton look at how the continued absence of approved products affecting the management of NASH patients.