FDA

FDA Draft Guidance on General Wellness Devices: A Primer

FDA Draft Guidance on General Wellness Devices: A Primer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.

Five things for pharma marketers to know: Tuesday, February 17

Five things for pharma marketers to know: Tuesday, February 17

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Bayer exec may be Sanofi's new CEO, GSK gets a new North American Pharma lead, and Pfizer sends painkiller ALO-02 to the FDA.

OPDP finds many flaws with Luitpold video

OPDP finds many flaws with Luitpold video

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The list of objections by the Office of Prescription Drug Promotion, which oversees medical advertising, is a familiar one, and includes concerns such as claims that go beyond the approved indication.

Five things for pharma marketers to know: Tuesday, February 10

Five things for pharma marketers to know: Tuesday, February 10

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FDA's latest guidance says it is ok to reduce the amount of risk information in print ads, Google amplifies the health information it will serve up with searches and HBO's John Oliver takes on pharmaceutical marketing.

Five things for pharma marketers to know: Thursday, February 5

Five things for pharma marketers to know: Thursday, February 5

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FDA commissioner Margaret Hamburg has stepped down; Pfizer acquires Hospira for $15.2 billion, AstraZeneca buys Actavis's branded respiratory business.

FDA simplifies compassionate use application

The original required 26 bits of information and seven attachments.

J&J's Imbruvica snares fourth indication

J&J's Imbruvica snares fourth indication

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The label will now include Waldenstrom's macroglubulinemia.

Five things for pharma marketers to know: Thursday, January 29

Five things for pharma marketers to know: Thursday, January 29

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Former FDA chief tells court J&J knew of Risperdal risk, pay-for-delay deals get new court criteria, lawmakers may declare pharmacists healthcare providers.

NPS drug approval bolsters Shire acquisition decision

NPS drug approval bolsters Shire acquisition decision

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The FDA approved NPS Pharmaceuticals's rare-disease drug Friday. The company, which Shire shelled out $5.2 billion to buy, expects it to hit the market during the second-quarter.

FDA appoints Office of Generic Drugs director

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

FDA to study impact of shorter DTC risk list

FDA to study impact of shorter DTC risk list

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The FDA is looking into whether abbreviated risk information is a good idea for DTC.

Pfizer cancer drug skips FDA advisory panel

Pfizer cancer drug skips FDA advisory panel

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The FDA told Pfizer that it isn't bothering with a committee review for the experimental breast cancer drug Ibrance (palbociclib). The part two news exciting investors: Pfizer and the FDA are already talking labels.

MM&M's top reads of 2014

MM&M's top reads of 2014

A look at the content that grabbed most reader interest over the past year.

FDA 2014 approvals outpace those of 2013

FDA 2014 approvals outpace those of 2013

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The regulator noted in its early 2014 retrospective that it set a high mark for the number of approved rare disease drugs this year, and that insufficient information is the reason many breakthrough status requests get bounced.

FDA tempers opioid approval impact

FDA tempers opioid approval impact

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The Center for Drug Evaluation and Research's director says there is a need for new opioids and cuts off dosing comparisons between extended-release and immediate-release opioids.

Five things for pharma marketers to know: Thursday, November 20

Five things for pharma marketers to know: Thursday, November 20

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CRS asks if high prices are a tool to offset CMS rebates, the FDA adds another DTC study to its lineup, and the NIH proposes making more clinical trial data public.

FDA delays rule on generic drug labeling amid controversy

As generic drug use soars, the agency intends to "create parity" in label-change rules for brands and generics.

Five things for pharma marketers to know: Tuesday, November 18

Five things for pharma marketers to know: Tuesday, November 18

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Ackman walks away with $2.5 billion, despite no Allergan deal; Ranbaxy sues FDA over generic Nexium rights; Indian government's Health Ministry recommends breaking BMS cancer drug patent.

FDA clears new tool for Ebola arsenal

A US Senate bill would also make treatments for the disease eligible for priority review vouchers.

FDA adds language to GERD drugs

The new language is in response to a 2011 citizen's petition.

Five things for pharma marketers to know: Friday,  October 17

Five things for pharma marketers to know: Friday, October 17

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Amgen sues Sanofi and Regeneron over PCSK9 patents; FDA panel wants Chantix black box to stay; Valeant-Allergan uproar rises in pitch; Pharmacyclics and Roche team up against CLL; and GSK's Ebola vax may "miss" the current crisis.

Panel seems to like Novartis drug

Pre-review documents indicate a favorable opinion of the IL-17 inhibitor secukinumab.

New FDA division launches Jan. 1

Resignations stymied the Office of Pharmaceutical Quality's beginning.

Shire delays ADD medication submission

The company is working with the FDA on new clinical trial requirements.

Five things for pharma marketers to know: Friday, October 3

Five things for pharma marketers to know: Friday, October 3

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Salix-Cosmo tax-inversion deal quashed, chronic heart failure market set to expand, rising generic drug prices get lawmakers' attention, NICE gives leukemia drug a thumbs-down, FDA has a good rep

Pacira gets OPDP opioid promotion Warning Letter

Pacira gets OPDP opioid promotion Warning Letter

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The FDA's Office of Prescription Drug Promotion says Pacira's promotional materials for Exparel are "extremely concerning," but the drugmaker tells investors the fuss is probably because opioids have been getting a lot of attention lately.

Advocates want FDA's Hamburg out

The reason: opioids.

Five things for pharma marketers to know: Friday, September 19

Five things for pharma marketers to know: Friday, September 19

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Lilly's weekly GLP-1 shot is approved, BI expands its lung-cancer portfolio, GSK's China investigation closes, NY proposed Sovaldi triage and India imposed price limits on 36 new medicines.

Novo seeks liraglutide obesity indication

Novo seeks liraglutide obesity indication

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An FDA advisory panel will consider evidence supporting a weight-loss indication Thursday.

Merck scores first US PD-1 approval

Merck scores first US PD-1 approval

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The FDA approved the drug previously known as pembrolizumab, now known as Keytruda, for patients with unresectable or metastatic melanoma who have taken Bristol-Myers Squibb's Yervoy (ipilimumab).

 

Did you miss January's Top 40 Healthcare Transformers issue? Read how these inventors, strategists, entrepreneurs and wonks are challenging, disrupting and otherwise transforming the healthcare business. And join us April 30 to honor them at the Transforming Healthcare Dinner. Click here.

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