Are You Missing Important FDA News and Reports? - FDA Webview is the Solution

2009-03-03 23:07:05 -

Are You Missing Important FDA News and Reports? - FDA Webview is the Solution

Save wasted time trying to stay on top of Food and Drug Administration (FDA)-related issues with FDA Webview (www.fdaweb.com) - the Internet's leading, online daily investigative journalism news service focused exclusively on FDA healthcare issues.

During the past week, FDA Webview published over 90 individual news reports covering FDA enforcement, compliance and other issues. Among the top reports were:

Obama Budget Backs Generic Biologics, Reimportation - President Obama's FY 2010 budget release lacks any specifics on potential resource increases for FDA program areas, but it does signal support for allowing generic biologic approvals and permitting drug reimportation.

FDA Stand on Ranbaxy Means GMP Compliance isn't Necessary - Consulting editor John Scharmann reviews FDA's latest decision on Ranbaxy's continuing CGMP problems and says it means compliance with those regulation is no longer necessary.

Obama Taps Sebelius to Lead HHS - President Obama names Kansas governor Kathleen Sebelius as his nominee to head the Department of Health and Human Services.

FDA Owns Up to Panel ‘Error' on Lilly Input - FDA says an error by lower-level staffers led to removing cardiologist Sanjay Kaul from an advisory committee considering Lilly's prasugrel.

Drug Safety Pressure Fuels DDMAC Activities During his annual DDMAC enforcement update, Division director Tom Abrams says safety information presentations in drug company advertising and promotional pieces will continue to be a primary focus at the agency.

House Committee Takes Up Tobacco Again - The House Energy and Commerce committee plans a business meeting 3/4 to mark-up the Family Smoking Prevention and Tobacco Control Act.

Burr Bill Would Put Tobacco in New HHS Agency, Not FDA - Senator Richard Burr (R-NC) plans to introduce legislation that would establish a new regulatory agency under Health and Human Services to regulate tobacco, a move that would not overburden FDA as a previous bill proposed.

Let's Find Someplace Else to Put Tobacco Regulation - Washington commentator Robert F. Steeves challenges all who are concerned about the condition of FDA to come together and propose a non-FDA/HHS situs for regulating tobacco.

DDMAC Cites ‘Unreleased' GSK Letter on Avodart - In an unprecedented move, DDMAC uses an unreleased notice-of-violation letter sent to GlaxoSmithKline to illustrate common promotional errors made by drug marketers.

Latest FDA Warning Letters - In its latest batch of Warning Letters, FDA cites Amedica, Cyclotron Center, EyeKon Medical, Health Science Center, Prime Enterprises, Lynette Stewart, South Beach Supplements, and Washington Hospital IRC.

Dems Propose 19% FDA Budget Hike, Want Results - House Democrats propose a 19% increase in FDA funding over the 2008 level and say they expect to see improved drug, device, biologics, and food safety as a result.

J&J Ordered to Pay $4.4 Million in Marketing Case - A West Virginia court imposes a $4.475 million civil penalty on J&J for deceptive marketing of its Risperdal and Duragesic.

Waxman Jumps on FDA Advisor ‘Disinvitation' - Reps. Waxman and Stupak ask FDA and Lilly for information and documents relating to the decision to disinvite Sanjay Kaul from an advisory committee meeting on prasugrel.

FDA and KV Pharma Sign Consent Decree - FDA and KV Pharmaceutical Co. enter into a consent decree over the company's ongoing GMP troubles.

Retention is a Problem in FDA Investigator Training - Consulting editor John Scharmann casts a skeptical eye on Congress' hiring goals for FDA and says that retention is the real problem.

Better Investigator Training a Pressing Need at FDA - Consulting editor John Scharmann finds Greed the main culprit in the contaminated peanut butter catastrophe but says that doesn't detract from a pressing need for better hands-on investigator training at the agency.

Could Clinical Data Publication by FDA Hurt Innovators? - Editor Jim Dickinson reviews a reader's comment on a proposal that FDA publish clinical trial data and FDA reviews on 'inactive' drug submissions and suggests the benefits might outweigh possible adverse effects on innovation.

Lawmakers to Take on Device Preemption and Approvals This Congress Rep. Frank Pallone (D-NJ) says he expects the House Energy and Commerce committee will hold hearings this session to question whether CDRH's process for approving devices is adequate.

Torti Cites Progress in FDA's Science Base - Acting commissioner Frank Torti says FDA has developed overarching scientific principles and is implementing programs to carry them out to strengthen the agency's science base.

Study Casts Doubt on Chantix Adverse Events - Researchers say people with a likely history of depression who take Pfizer's Chantix to help quit smoking do not report more severe mood symptoms compared to people with no history of depression.

FDA Needs More Supplement Authority: GAO - GAO says FDA needs additional legal authority to regulate dietary supplements so it has the information needed to obtain and respond to adverse event reports.

FDA Sends Complete Response and Warning Letter to Genzyme - FDA issues Genzyme a complete response letter on Lumizyme (alglucosidase alfa), indicated for treating Pompe disease, and a Warning Letter citing the product's manufacturing facility.

Documents Suggest AZ ‘Buried' Seroquel Trial Data - Unsealed court documents show AstraZeneca officials discussing burying unfavorable Seroquel trial results and reporting only favorable data.

Whistleblower Suit Unsealed on Anemia Drug Marketing - A whistleblower says Amgen and Wyeth illegally marketed Aranesp and Enbrel to gain market share over competitor Procrit.

Device Companies Say They Support Comparative Effectiveness - Medical device manufacturers say they support comparative effectiveness research if it isn't only focused on finding the cheapest treatment.

FTC to Step Up ‘Pay-for-Delay' Action - Expected FTC chairman Jon Leibowitz says the commission will have the Obama administration's backing in working to eliminate branded drug company payments to prevent generics from entering the market.

Forest Charged Over Alleged Off-label Promos - The U.S. government alleges that Forest Laboratories marketed antidepressants Celexa and Lexapro for unapproved pediatric uses and paid illegal kickbacks to induce physicians to prescribe the drugs

ACLA Joins Opposition to Genentech Petition - The American Clinical Laboratory Association asks FDA to deny a Genentech citizen petition calling for agency regulation of laboratory-developed diagnostic tests.

Delay in FDA Action on Tainted Heparin Syringes - Records indicate that FDA received complaints about contaminated AM2PAT heparin/saline syringes two years before it issued a recall notice.

Von Eschenbach Joins Consulting Firm - Former FDA commissioner Andrew von Eschenbach joins consulting firm Greenleaf Health as senior advisor.

Caraco Expects May FDA Re-inspection - Caraco Pharma says it expects an FDA reinspection in May to verify corrective actions that the company has implemented after receiving a 10/31/08 Warning Letter.


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