FDA

PhRMA's Washington wish list

May 21, 2012

PhRMA presented Washington with its legislative wish list - and a warning that plenty of other countries are trying to woo the industry away from the US.
 

RX-to-OTC proposal gets mixed reviews

May 14, 2012

Industry and physician groups expressed wary support for the FDA's "new paradigm" drug proposal, which would create a nonprescription "Behind the Counter" class of drugs available through pharmacists.
 

Humira on solid ground, analysts say, despite vote on Pfizer hopeful

May 10, 2012

The general consensus surrounding the FDA advisory panel's 8-2 vote in favor of Pfizer's rheumatoid arthritis hopeful tofacitinib yesterday was that Abbott's Humira doesn't have to watch its back.
 

Report: FDA hitting PDUFA targets, critics be darned

May 03, 2012

The latest word from the Government Accountability Office: back off the FDA. The government research agency's newest report says the FDA is plowing through new- and biologics- drug applications at a speedy pace.
 

Social media an outcomes listening post for pharma

March 27, 2012

FDA issues may deter drugmakers from engaging in social media, but that's no excuse to ignore what audiences are saying on these platforms, say pharma and device firms.
 

Shire exits Fabry's market, citing costs as FDA weighs more research

March 15, 2012

Shire has pulled its drug, Replagal, from FDA review. The company was set to go before the agency next month, but preliminary talks indicated the FDA was going to require more testing.
 

FDA's 45-day TV ad review "shot clock" in guidance

March 12, 2012

TV ads for most prescription drugs must be submitted to FDA for pre-clearance 45 days before the manufacturer intends to air them, according to an FDA draft guidance in tomorrow's Federal Register.
 

An FDA denial, but not the last word on Merck combo lipid drug

March 06, 2012

An experimental lipid-lowering combo drug developed by Merck hit a snag, but its real test is yet to come, says one analyst.
 

Med Ed Report briefs—March 2012

March 01, 2012

News on FDA, Med-IQ, the American Medical Student Association, Best Practices, the American College of Physicians and CECity
 

FDA study finds little harm in 'distracting visuals'

March 01, 2012

An FDA study on the power of background visuals found no evidence that consumer understanding of risk info is affected by the "emotional (affective) tone of images."
 

As I See It: Global systems for quality and safety

Peter Pitts March 01, 2012

It's time for a regulatory Marshall plan to help build global systems for quality and safety
 

Sens. Klobuchar, Collins push drug-shortage bill

March 01, 2012

U.S. senators Amy Klobuchar and Susan Collins are trying to quickly pass a bill addressing the growing drug shortage problem
 

User-fee inaction could cause logjam

March 01, 2012

Congressional inaction could lead to a huge new products-review backlog, according to FDA Matters editor Steven Grossman.
 

FDA to study "corrective" ads

February 29, 2012

The FDA will study the impact of corrective advertising on consumer misperceptions of drug safety and efficacy.
 

Company news: Biogen-Idec, Bristol-Myers Squibb and Pfizer

February 29, 2012

Biogen-Idec is submitting its multiple sclerosis drug BG-12 for formal FDA scrutiny.
 

Industry group releases digital best practices

February 06, 2012

Weary of FDA foot-dragging on digital and social media guidance for pharmas, a group of 60-some industry digerati have put together guidelines of their own.
 

FDA study casts doubt on danger of "distracting visuals"

January 31, 2012

An FDA study looking at the power of background visuals to distract viewers from the often-ominous risk info read in the "major statement" section of TV drug ads found no evidence that consumer understanding of risk info is affected by the "emotional (affective) tone of images.
 

FDA gives guidance on brand, generic names in ads

January 26, 2012

The FDA issued guidance clarifying narrow questions of scientific or generic name placement in ads and labeling in different media, including electronic media.
 

Tysabri gets boost from label change, new diagnostic

, Marc Iskowitz January 23, 2012

Biogen Idec and Elan, which market Tysabri for multiple sclerosis, won approval to add new safety information to the drug's label that could boost sales by helping doctors avoid a serious adverse event.
 

Company news: Gilead, Pfizer and Wolters Kluwer

December 29, 2011

Two potential blockbusters in the pharma pipeline took another step toward reaching market, as US regulatory authorities assigned PDUFA dates for Gilead Sciences' Quad pill and for Pfizer's tofacitinib.
 

DOJ hit pharmas for $2.2 billion in 2011 False Claims Act cases

December 20, 2011

Pharmas shelled out $2.2 billion in False Claims Act fines and settlements with the Justice Department this year as the feds' healthcare fraud haul hit an all-time high.
 

How Genentech cut journal ads across all Avastin indications

December 05, 2011

Well before the FDA revoked Avastin's approval in breast cancer, Roche's Genentech unit deeply cut the professional media plan for the drug, the company said.
 

Since Vioxx scare, tough times for industry R&D, study finds

December 01, 2011

A review of 450 New Molecular Entities spanning a decade and a half found two distinct eras of drug R&D - one of abundance and one of scarcity, hinging on the September, 2004 withdrawal of Merck's Vioxx.
 

Merck wraps up Vioxx litigation with feds, states: $1b in fines, new CIA

November 22, 2011

Seven years after the biggest drug safety scandal since thalidomide was found to cause birth defects, Merck and the Justice Department announced a nearly $1 billion settlement of litigation over Vioxx, the Cox-2 pain drug found to cause strokes and heart attacks.
 

Par Pharma suit could set up off-label court showdown

October 18, 2011

Par Pharmaceutical last week asked a federal court to tell the FDA to back off and allow the company to detail docs about using its Megace ES to treat AIDS-related wasting.
 

Company news: FDA, Ranbaxy, Daiichi Sankyo and ImpactRx

October 06, 2011

The FDA issued Driving Innovation, a blueprint for fostering American biomedical innovation, reiterating a prior commitment to reform regulation and announcing policies aimed at facilitating personalized medicine.
 

Say so long to DDMAC as FDA's OPDP levels up

September 19, 2011

The FDA gave its Office of Medical Policy a long-awaited org chart upgrade, making it a "super office" and giving the department formerly known as the Division of Drug Marketing, Advertising and Communication, or DDMAC, a new acronym: OPDP.
 

FDA, industry agree on PDUFA deal to speed NME reviews

September 01, 2011

The FDA and the biopharma industry have agreed in principle on a revamp of the Prescription Drug User Fee Act (PDUFA), by which pharmas provide nearly two-thirds of what the agency spends on drug reviews.
 

Pfizer's Xalkori and Abbott test show promise in personalized medicine, companion diagnostics

August 30, 2011

The FDA's approval of Pfizer's Xalkori (crizotinib) represents a leap forward for both personalized medicine and Pfizer's R&D turnaround, but its commercial success hinges on a pricey diagnostic array by Abbott's Vysis.
 

FDA to IOM: More work? No thanks

August 11, 2011

The FDA is moving cautiously on a call by the Institute of Medicine to scrap the approvals process for many medical devices.
 

Video Exclusive

Web Exclusives

Five industry experts advise specialty pharma company on digital strategy

April 20, 2012

Specialty pharma company POZEN assembled a crack team of experts to help shape its digital strategy. Not only did POZEN share with us the text from their contributions, but you can watch exclusive video clips of their valuable perspectives right here.
 

MM&M Awards 2011 HIghlights

The Best MM&M Awards Ever!

MAHF Ceremony 2012

Photos from the Medical Advertising Hall of Fame Awards ceremony
 
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