FDA guidelines for payer, off-label communications: OK as long as 'truthful'

FDA guidelines for payer, off-label communications: OK as long as 'truthful'

Two FDA guidance documents aim to help pharma companies show the value of their drugs to payers beyond what's included in FDA labeling.

Marijuana: a green grey zone for patients, doctors, and pharma companies

Marijuana: a green grey zone for patients, doctors, and pharma companies

Legalization of the drug for medical use is already having an impact on prescription patterns. But for patients and doctors alike, there are a lot of unanswered questions.

GDPR: How to make sure your business is ready

GDPR: How to make sure your business is ready

As of May 25, Europe's groundbreaking General Data Protection Regulation (GDPR) will take effect, fundamentally changing the way businesses and government agencies deal with personal data.

No slowing down: Orphan drug designations skyrocket in 2017

No slowing down: Orphan drug designations skyrocket in 2017

The pace may even pick up again this year.

FDA to study HCP views of pharma promotions this year

FDA to study HCP views of pharma promotions this year

The research will also cover topics including disease awareness ads.

Sandoz lines up potential third-to-market Humira copy

Sandoz lines up potential third-to-market Humira copy

Although if approved, it's not likely to launch in the U.S. for quite some time.

NORML balances federal, local action after Cole memo reversal

NORML balances federal, local action after Cole memo reversal

Once Attorney General Jeff Sessions reversed the Cole memo, NORML began applying pressure both locally and nationally for changes in marijuana laws.

How will the pharma industry fare in 2018 under Trump?

How will the pharma industry fare in 2018 under Trump?

The first year of the Trump administration was kind to pharma, but it might not be so fortunate in 2018.

HHS nominee Alex Azar: Medicare Part B should negotiate drug prices

HHS nominee Alex Azar: Medicare Part B should negotiate drug prices

Alex Azar, previously a senior executive at Eli Lilly, proposed granting Part B the authority to negotiate lower prices.

OPDP issues third enforcement letter of 2017

OPDP issues third enforcement letter of 2017

The FDA's Office of Prescription Drug Promotion issued a warning letter to Amherst Pharmaceuticals and Magna Pharmaceutical.

Limits on pharma payments to doctors back on policy menu

Limits on pharma payments to doctors back on policy menu

A mini wave of state-level rule-making has thrust the issue of restrictions on pharma payments to medical professionals back into the spotlight.

The FDA issues its second enforcement letter of 2017

The FDA issues its second enforcement letter of 2017

The OPDP has only issued two letters in 2017, compared to 11 last year.

PhRMA criticizes the FDA's research into drug advertising and promotion

PhRMA criticizes the FDA's research into drug advertising and promotion

The lobbying group said it's unclear what the agency's goal is with this research and how it promotes public health.

Johnson & Johnson in breach of U.K. rules over Nicorette marketing

Johnson & Johnson in breach of U.K. rules over Nicorette marketing

Johnson & Johnson has breached the U.K.'s drug regulation code in three places in promotions for smoking cessation product Nicorette.

Bill to allow imported drugs from Canada aims to create competition

Bill to allow imported drugs from Canada aims to create competition

The Congressional Budget Office says that Sanders' bill would save the U.S. federal government nearly $7 billion over the next decade.