FDA Draft Guidance

Five things for pharma marketers to know: Friday, May 1

Five things for pharma marketers to know: Friday, May 1

By

Nexium tops the list of Medicare's spending on brand drugs; Gilead Sciences doubles its first-quarter profit; Pfizer reportedly wants to buy a rare-disease drug company

FDA may tighten drug environmental rules

Draft guidance would require applications for drugs that interact with or include hormones to include environmental impact assessments.

Five things for pharma marketers to know: Thursday, March 12

Five things for pharma marketers to know: Thursday, March 12

By

The SEC said some company drug prices can be made public, 23andMe launched an R&D division, and Public Citizen is asking the FDA to withdraw a proposal it says will undermine drug safety information.

FDA releases new e-informed consent guidance in bid for more efficient trials

FDA releases new e-informed consent guidance in bid for more efficient trials

By

The agency hopes the adoption of electronic informed consent measures could help participants retain and understand information as well as allow quicker timing of updates.

FDA Draft Guidance on General Wellness Devices: A Primer

FDA Draft Guidance on General Wellness Devices: A Primer

A treatise on understanding the FDA's latest guidance of low-risk general wellness products.

New exclusivity rules confound

A draft guidance publication date determines whether drugmakers get three or five years of market exclusivity.

FDA Guidance expands environmental perspective

The regulator is issuing draft guidance to address gene therapies.

Compounders get version of PDUFA

The FDA has issued draft guidance that funds FDA inspection of some drug compounders.

FDA drafts patient-centric CFS guidance

Draft guidance indicates the regulator is open to using patient experience as criteria for chronic fatigue syndrome treatments.

Off-label guidance may not be publishing boon

Off-label guidance may not be publishing boon

By

The FDA's proposed upgrade to its off-label distribution guidelines has some new features, but experts say it is unclear if this means more dollars will flow toward reprints.

FDA eases rules on ads in social media

FDA eases rules on ads in social media

The draft guidance is mostly procedural, and more guidance is expected, but experts say it does include some long-awaited clarity for advertisers.

FDA exempts most mobile apps from scrutiny

FDA exempts most mobile apps from scrutiny

By

The agency issued final guidance on mobile apps, saying it will focus only on a subset that present the greatest risk to patients if they don't work correctly.

Advisory panel backs GSK drug for COPD

By

The advisory panel endorsed the treatment with an 11-2 vote.

Business briefs: GSK, Roche, Biogen Idec, Forest

FDA draft guidance for generic Advair hits GSK's stock; US looks into GSK's China conduct; Roche invests in cancer and hep. B research; Biogen inks a Parkinson's partnership; Forest names former B&L chief as CEO

FDA move gives Purdue edge in painkiller market

FDA move gives Purdue edge in painkiller market

By

Generic Opana ER got the go-ahead from FDA, exposing the drugmaker to generic competition -- unlike Purdue, whose tamper-proof painkiller won standalone status.

Email Newsletters


As US pharma continued its quest for a Grand Prix at the Lions Health international festival of creativity, MM&M went on location to Cannes, France. Missed our coverage from June? Now, we're giving you an opportunity to catch up on some of what you missed. Download our e-book on the two-day festival, recapping the event, rounding up the best of the speakers, offering perspective and listing all of the winners. Click here to download.


The most recent MM&M Skill Sets Live event surveyed a range of issues relating to one of the hottest promotional spaces in healthcare. Speakers and panelists at the morning-long session, including promotional- and multichannel-minded executives from GSK, Epocrates, Treato and Montefiore Medical Center, weighed in on topics designed to help marketers demystify the challenges associated with non-personal promotion. Click here.