ANNOUNCEMENT

MedCity CONVERGE July 9-10 in Philly gathers payers, providers, medtech, pharma, digital health, policymakers & more.

Topic: FDA

Key stakeholder Teva tries to stay out of limelight in drug controversy

Key stakeholder Teva tries to stay out of limelight in drug controversy

May 17, 2013 5:14 am by | 0 Comments

The recent controversy surrounding the morning-after contraceptive pill called Plan B One-Step has been argued in political, regulatory, and legal circles. But Teva Pharmaceuticals Ltd., which makes the drug and ... Read more
What’s behind the FDA’s push for more patient engagement (hint: it’s not that everyone else is doing it)

What’s behind the FDA’s push for more patient engagement (hint: it’s not that everyone else is doing it)

May 13, 2013 11:04 am by | 0 Comments

Lately, the U.S. Food and Drug Administration seems to be doing a bit of re-branding: A new Patient Network site is anchoring a push for more patient engagement in the ... Read more
FDA wants more patients to learn about and offer feedback on drug/device approvals

FDA wants more patients to learn about and offer feedback on drug/device approvals

April 26, 2013 9:13 am by | 0 Comments

As part of its effort to be more transparent and loop patients into its processes and policies, the U.S. Food and Drug Administration this week launched a new website called ... Read more
Is limited social media guidance from FDA resulting in more violations for pharma?

Is limited social media guidance from FDA resulting in more violations for pharma?

April 3, 2013 3:36 pm by | 1 Comments

While the lack of FDA guidance on social media has kept some medical companies away from online channels where patients are gathering. But that fear may not be as real ... Read more
3 charts on sequestration, healthcare innovation and the Affordable Care Act

3 charts on sequestration, healthcare innovation and the Affordable Care Act

March 27, 2013 9:00 am by | 0 Comments

On Monday, the sequestration cuts are set to touch down on Medicare and cause a 2 percent drop in reimbursement payments made to doctors, hospitals and other providers.Dr. Paul Keckley, ... Read more
Hemispherx says FDA rejects fatigue drug application

Hemispherx says FDA rejects fatigue drug application

February 4, 2013 9:25 pm by | 0 Comments

(Reuters) - Hemispherx Biopharma Inc said U.S. regulators had declined to approve its new drug application for Ampligen, its experimental drug for treating chronic fatigue syndrome, five years after the ... Read more
Address the complexity of social media in pharma by following your customers

Address the complexity of social media in pharma by following your customers

January 9, 2013 5:48 pm by | 0 Comments

Want to reach consumers? “Get social,” experts say. Create Facebook and Twitter accounts. Blog about issues that are buzzworthy and important to customers. Interact with consumers to discuss their preferences ... Read more
Invacare divests medical supplies unit, reaches agreement with FDA on manufacturing issues

Invacare divests medical supplies unit, reaches agreement with FDA on manufacturing issues

December 24, 2012 12:06 pm by | 0 Comments

It’s a fitting conclusion to a tumultuous year for home health supply company Invacare Corp. (NYSE: IVC). In an effort to “reduce complexity” in its business and focus on its ... Read more
FDA grants priority review of Ariad leukemia drug

FDA grants priority review of Ariad leukemia drug

October 24, 2012 7:35 am by | 0 Comments

(Reuters) - The Food and Drug Administration has agreed to a priority, or six-month, review of Ariad Pharmaceuticals Inc's experimental leukemia drug ponatinib, the company said on Wednesday.The deadline for ... Read more
FDA advisers back NPS’s drug for short bowel syndrome

FDA advisers back NPS’s drug for short bowel syndrome

October 16, 2012 3:47 pm by | 0 Comments

(Reuters) - U.S. drug advisers on Tuesday backed a drug to treat a rare and serious bowel disorder for which there is no long-term treatment available in the United States.A ... Read more
FDA shuts down 18,000 illegal websites, seizes $10.5 million worth of drugs

FDA shuts down 18,000 illegal websites, seizes $10.5 million worth of drugs

October 4, 2012 9:30 am by | 0 Comments

(Reuters) - The U.S. Food and Drug Administration on Thursday said it has cracked down on thousands of online pharmacies for selling potentially unsafe, unapproved or fake pharmaceuticals, including the ... Read more
FDA gives orphan drug status to Cleveland BioLabs’ phase 1 drug for liver cancer

FDA gives orphan drug status to Cleveland BioLabs’ phase 1 drug for liver cancer

October 4, 2012 8:00 am by | 0 Comments

A liver cancer drug being developed by a joint venture between Cleveland BioLabs (NASDAQ:CBLI) and a Russian-based venture fund was granted orphan drug status by the U.S. Food and Drug ... Read more
Lilly gets FDA approval for prescribing Tradjenta tablets

Lilly gets FDA approval for prescribing Tradjenta tablets

August 17, 2012 2:58 pm by | 0 Comments

Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company (NYSE: LLY) today announced the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Tradjenta ... Read more
Is it drug manufacturing or the practice of medicine? Stem cell therapy debate just getting started

Is it drug manufacturing or the practice of medicine? Stem cell therapy debate just getting started

August 3, 2012 1:07 pm by | 0 Comments

The latest round of a stem cell debate may have concluded, but as far as the lawyers representing an orthopedics company that has offered stem cell treatments are concerned, it’s ... Read more
FDA issues warning about Covidien brain device that has killed nine

FDA issues warning about Covidien brain device that has killed nine

July 2, 2012 5:49 pm by | 0 Comments

The Food and Drug Administration issued a warning to physicians and patientsMonday about the Onyx Liquid Embolic System where the catheter used to deliver the liquid can get stuck inside ... Read more