Regulatory

GW Pharma's Justin Gover on marketing the first cannabis-based drug

GW Pharma's Justin Gover on marketing the first cannabis-based drug

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11 questions for the GW CEO on the watershed moment.

Kim Kardashian deletes Instagram post promoting morning sickness drug

Kim Kardashian deletes Instagram post promoting morning sickness drug

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Kardashian's previous posts for Duchesnay's morning sickness treatments were slammed by the FDA for not including side effects or risk information.

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

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

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

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.

One month out: Top 6 steps for GDPR compliance

One month out: Top 6 steps for GDPR compliance

On May 25, 2018 the European Union's General Data Protection Regulation, commonly called GDPR, will become not only the law of the land in Europe but across the globe.

Five things for pharma marketers to know: Tuesday, December 12, 2017

Five things for pharma marketers to know: Tuesday, December 12, 2017

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FDA issues prescription drug promotion guidance; FDA approves first follow-on biologic of Lilly's Humalog; drugmakers allegedly hired nurses to promote drugs

Tax Bill Is Good News for Life Sciences and Marketing

Tax Bill Is Good News for Life Sciences and Marketing

Although it's a long way from the president's desk, the Tax Cut and Jobs Act of 2017 contains plenty of good news for the life sciences industry and its marketing partners.

Five things for pharma marketers to know: Wednesday, September 27, 2017

Five things for pharma marketers to know: Wednesday, September 27, 2017

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AbbVie adds context to CEO's comments on drug pricing; Pandora makes a play for pharma ad dollars; shortages expected of drugs manufactured in Puerto Rico

Five things for pharma marketers to know: Friday, August 18, 2017

Five things for pharma marketers to know: Friday, August 18, 2017

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Lawmakers to investigate pricing of MS drugs; Mylan will pay $465 million to resolve EpiPen allegations; the FDA approves Pfizer's new cancer drug

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

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

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

Questions About Promotion Prompt Marketers to Develop Code of Ethics

Questions About Promotion Prompt Marketers to Develop Code of Ethics

That's why the Coalition for Healthcare Communication is focused on creating self-regulatory guidelines.

Astellas reprimanded by U.K. drug regulator

Astellas reprimanded by U.K. drug regulator

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The drugmaker has been handed a "public reprimand" by the U.K.'s Prescription Medicines Code of Practice Authority after the creative director of an unnamed agency used the company's patient support materials on its website.

Five things for pharma marketers to know: Wednesday, March 1, 2017

Five things for pharma marketers to know: Wednesday, March 1, 2017

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Trump reiterates call to bring down drug prices; Novartis renews its focus on immunotherapies; a new bill would allow drugs to be imported

The Highly Regulated Healthcare Industry Can Draw in Top Marketers

The Highly Regulated Healthcare Industry Can Draw in Top Marketers

Today's ambitious marketers and media people want to be the ones to not only figure out how to work within the regulations but also to create better work than ever before.

Warning letters most often stem from missing risk information

Warning letters most often stem from missing risk information

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The number of warning and untitled letters has dropped in recent years. Only four letters have been sent so far this year, compared to 28 in 2012.

Five things for pharma marketers to know: Tuesday, July 19, 2016

Five things for pharma marketers to know: Tuesday, July 19, 2016

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The FDA declines to approve Novartis biosimilar; GSK partners with Apple's ResearchKit; drugmakers partner with Lyft for clinical trial participants

Five things for pharma marketers to know: Thursday, July 14, 2016

Five things for pharma marketers to know: Thursday, July 14, 2016

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The FDA expands use for Pfizer's Prevnar 13 vaccine; an FDA panel votes in support of Novartis biosimilar; U.S. healthcare spending rises 5.5% in 2015

Five things for pharma marketers to know: Thursday, June 16, 2016

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A government watchdog criticizes the FDA; the FDA strengthens kidney warnings for Invokana and Farxiga; people with diabetes are living longer

Leadership Exchange: Social Listening

Leadership Exchange: Social Listening

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Social listening can help all along the value chain—from research and discovery to developing marketing plans and strategy.

FDA panel says benefits outweigh risks for Lilly's lung-cancer drug

Eli Lilly's lung-cancer antibody, necitumumab, has incremental benefits, according to an FDA advisory panel.

Drug industry's CME support swings to a 2% gain

Drug industry's CME support swings to a 2% gain

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Last year's increase in CME support from manufacturers came after six straight years of declining budgets.

FDA advisory panelists describe decision to recommend approval of "female Viagra"

FDA advisory panelists describe decision to recommend approval of "female Viagra"

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Three panelists from the FDA's advisory panel offered their views on the panel's decision to recommend approval of Sprout Pharmaceuticals' flibanserin

Steady Leadership, Focus on Infrastructure Expected from the FDA's "Acting" Head

Steady Leadership, Focus on Infrastructure Expected from the FDA's "Acting" Head

Dr. Stephen Ostroff took over as the FDA's acting commissioner when Dr. Margaret Hamburg stepped down in March.

New bill seeks to spur FDA to form clearer social media rules

New bill seeks to spur FDA to form clearer social media rules

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Rep. Billy Long introduced legislation that is meant to push the FDA to implement clearer guidelines for regulating drug product information on social media.

Five things for pharma marketers to know: Friday, May 22

Five things for pharma marketers to know: Friday, May 22

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Amgen's PSCK9 inhibitor gets a position opinion in the EU; the FDA plans to study how spouses influence perception of DTC ads; Botox may relieve depression

Five things for pharma marketers to know: Monday, May 4

Five things for pharma marketers to know: Monday, May 4

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Drugmakers engage early with insurers; patients push for implant to be pulled from the market; about one-third of new drugs qualify for special approval pathways

 Five things for pharma marketers to know: Thursday, April 9

Five things for pharma marketers to know: Thursday, April 9

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Novartis reported highest drug sales in 2014; state Medicaid programs spent $1.33 billion on hepatitis-C drugs; former FDA commissioner argues against shortening regulatory review times

FDA open-data platform gains traction

FDA's application programming interfaces, or openFDA, reached 6,000 users less than a year after its launch.

FDA updates DTC ad policy on risk information

FDA updates DTC ad policy on risk information

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FDA posted a revised draft guidance document on its brief summary and adequate directions for use concerning risk information in DTC print ads to reflect "recent social science research."

FDA appoints Office of Generic Drugs director

FDA has named Kathleen Uhl as permanent director of the Office of Generic Drugs.