Regulatory

Pharm Exec interviews the FDA commissioner, who is building support by combating opioid abuse and advancing innovation.

FDA officials make efforts to better manage the increasing amount of applications for new drugs that treat disease in innovative ways and include new kinds of clinical research, starting with a plan to restructure the Office of New Drugs (OND) in the Center for Drug Evaluation and Research (CDER).

Public health authorities and the biomedical research community are seeking new strategies to address global health threats, writes Jill Wechsler.

Impact, challenges and the importance of ensuring readiness with ICH E2B (R3) EudraVigilance.

FDA is moving slowly in liberalizing off-label communications amid outrage over opioid promotion. Jill Wechsler reports.

After months of delay, Congress finally passed a $1.3 trillion omnibus budget bill March 22, 2018, just in time to avoid another government shut-down.

As part of FDA initiatives to reward innovation and promote patient access to medicines, the agency is working hard to support the development of high quality biosimilars and interchangeable products, Scott Gottlieb told a conference on March 7.

The public and policymakers seek more transparency in pricing and product development.

Adhering to new compliance legislation such as Identification of Medicinal Products (IDMP) can bring a pharma company benefits as well as challenges, writes Darren Cooper.

Advocates on all sides applauded the request to increase funding significantly for FDA under the Trump administration’s budget for fiscal year 2019.

Commissioner Scott Gottlieb has outlined FDA plans to continue the fight against opioid addiction and to prepare a “comprehensive plan” to bolster the market for biosimilars.

Low-cost follow-ons and biosimilars please payers but heighten competitive battles with brands.

Amidst the continuing clamor for government action to curb prescription drug prices, a more collaborative effort aims to broaden the debate to consider the full range of health care services and rates that affect spending in this area. Jill Wechsler reports.

In his State-of-the-Union address this week, President Trump continued his harangue about unfair drug prices in the U.S., but he surprised many observers by failing to call for full repeal of the Affordable Care Act.

Reflector reports on the EU's legislative move to push the fifty or so national and regional HTA organizations in Europe towards greater cooperation.

States will continue to press for price controls, while FDA will tackle opioids and promote innovation.

If confirmed as the next secretary of the Department of Health and Human Services (HHS), Alex Azar says that a top priority is to make drugs more affordable.

By enacting landmark tax reform legislation that makes major changes in the corporate tax structure, Congress this week delivered a significant Christmas present to President Trump - and to industry, writes Jill Wechsler.

In 2017, patients gained access to the first gene therapies and more orphan and breakthrough drugs.

Experts slam drug prices and endorse government price negotiations and curbs on drug advertising.

As FDA and industry near the halfway mark in the process for establishing a national electronic drug tracking system by 2023, there’s concern among pharma companies, wholesaler/distributors, and pharmacists about meeting the deadline

Jill Wechsler discusses the hot topic of how FDA should oversee combination products that incorporate a digital health component.

The GAIN Act creates a process for the Qualified Infectious Disease Product (QIDP) designation, which provides a range of incentives for developing antimicrobial therapies for combating resistant organisms. But while the program has been successful in driving innovation, commercial viability remains a question.

Medical use of marijuana for a broad range of conditions is expanding rapidly in the US, but the future for this market is still uncertain, writes Harriet Kozak.

Despite FDA approval of seven biosimilars through October 2017, only three have come to market due to heated patent disputes and continued debate over biosimilar naming and interchangeability, fueling concerns in the medical community about the safety of switching patients to new therapies.

While most pharma companies are in partial production using generators, few are operating at 100% capacity, writes Jill Wechsler.

Agency leaders go slow in weighing changes to DTC ads and off-label marketing.

FDA seeks to de-risk research and promote competition to achieve savings for patients and plans.