Recommended Pages at fdanews.com
Asthma Drugmaker Choking on FDA Form 483 Observations
fdanews.com — “Nephron Pharmaceuticals, a Fla.-based drugmaker, was handed a Form 483 after an FDA inspection found it failed to fully review unexplained discrepancies or failures of batches of albuterol sulfate solution to meet specifications.” View full resource at fdanews.com
Most Recently Shared on January 21, 2012 at 10:47 pm By:
Michael Blaiss, MD Doctor, Allergist, and Physician
Asthma Drugmaker Choking on FDA Form 483 Observations http://t.co/Li8UNALw
FDA, Trade Groups Agree on Biosimilars Fee Amount, Still Working on Structure
fdanews.com — “The FDA and biosimilars industry have agreed to a product development fee set at 10 percent of each year’s prescription drug marketing application fee, but the FDA is still working to define the fee structure.” View full resource at fdanews.com
Most Recently Shared on August 10, 2011 at 2:56 pm By:
RT @FDAnewsPharma: FDA, Trade Groups Agree on Biosimilars Fee Amount, Still Working on Structure http://bit.ly/qkir0E #fdasm #socpharm
Bayer’s European Patent for Yaz Revoked by Board of Appeal
fdanews.com — “The European Patent Office’s Board of Appeal is revoking Bayer HealthCare’s formulation patent for its Yaz, Yasmin and Yasminelle products — a blow to the blockbuster line of birth control pills.” View full resource at fdanews.com
Most Recently Shared on July 28, 2011 at 6:29 pm By:
RT @FDAnewsPharma: Bayer’s European Patent for Yaz Revoked by Board of Appeal http://bit.ly/qcYes3
J&J’s Antibiotic Drug Levaquin Gains a Dozen Generic Competitors
fdanews.com — “The FDA announced the first approvals of generic versions of Johnson & Johnson’s (J&J) blockbuster antibiotic Levaquin, as the product loses its exclusivity.” View full resource at fdanews.com
Most Recently Shared on June 29, 2011 at 6:16 pm By:
RT @FDAnewsPharma: J&J’s Antibiotic Drug Levaquin Gains a Dozen Generic Competitors http://bit.ly/lCGC9c
Low Success Rate for Phase II Trials Cause for Concern, Study Says
fdanews.com — “Decreasing success rates for Phase II drug candidates are cause for concern, as the overall attrition of late-stage drug development “seems to be unsustainability high,” a new Centre for Medicines Research (CMR) analysis says.” View full resource at fdanews.com
Most Recently Shared on May 31, 2011 at 8:00 pm By:
Richard G. Lanzara Health Professional
RT @FDAnewsPharma Low Success Rate for Phase II Trials Cause for Concern, Study Says http://bit.ly/mNMEmK #BioTech #Pharma
FDA Hands Philips Warning Over Design Changes, Complaint Handling
fdanews.com — “The FDA has warned Philips Medical Systems for unvalidated and unverified corrective design changes, as well as its complaint handling procedures.” View full resource at fdanews.com
Most Recently Shared on May 27, 2011 at 5:11 pm By:
Philips Medical News Health Business
FDA Hands Philips Warning Over Design Changes, Complaint Handling http://bit.ly/mjATua - #imaging
Study Challenges Tufts Report on Drug Development Costs
fdanews.com — “A new study claims figures on the cost of drug development, generated by a 2003 study from the Tufts Center for the Study of Drug Development (TCSDD) and widely cited by PhRMA, are wildly inflated and based on unverifiable data.” View full resource at fdanews.com
Most Recently Shared on April 6, 2011 at 3:07 pm By:
RT @FDAnewsPharma: Study Challenges Tufts Report on Drug Development Costs http://bit.ly/eFi0f8
FDA Misses Target to Release Social Media Guidance
fdanews.com — “The FDA has once again missed its target for releasing guidance on social media and internet marketing.” View full resource at fdanews.com
Most Recently Shared on April 4, 2011 at 3:43 pm By:
RT @FDAnewsPharma: FDA Misses Target to Release Social Media Guidance http://bit.ly/fTuOtY
Advisory Committee Recommends Lower Dose of Novartis’ Indacaterol
fdanews.com — “An FDA advisory committee agreed to recommend approval of a lower dose of Novartis’ chronic obstructive pulmonary disease drug indacaterol after finding that a high dosage version didn’t provide any additional benefit.” View full resource at fdanews.com
Most Recently Shared on March 14, 2011 at 2:09 pm By:
Juan C. Ivancevich, MD Doctor, Internist, Allergist, and Physician
FDA Advisory Committee Recommends Lower Dose of Novartis’ Indacaterol http://t.co/B7arodW
Federal Court Absolves Abbott of $1.7 Billion Patent Verdict
fdanews.com — “A federal appeals court has overturned a $1.7 billion patent-infringement verdict against Abbott Laboratories, saying the company did not infringe a Johnson & Johnson (J&J) patent on the blockbuster autoimmune disease treatment Humira.” View full resource at fdanews.com
Most Recently Shared on March 10, 2011 at 7:24 pm By:
RT @FDAnewsPharma: Federal Court Absolves Abbott of $1.7 Billion Patent Verdict http://bit.ly/dHrlBV
FDA Considers New Pilot Program to Improve Drug Review Process
fdanews.com — “The FDA and drugmakers are developing a pilot program designed to improve the agency’s drug review process as part of negotiations over the reauthorization of the Prescription Drug User Fee Act.” View full resource at fdanews.com
Most Recently Shared on March 4, 2011 at 3:52 pm By:
Great News from the #FDA: New Pilot Program to improve drug review process focuses on improved communications. http://bit.ly/dHdYUd #PhRMA
FDA Warns of Cancer Threat, Calls for Breast Implant Labeling Change
fdanews.com — “Manufacturers of breast implants will have to update their labeling to warn of a possible link between the devices and a rare form of non-Hodgkin’s lymphoma.” View full resource at fdanews.com
Most Recently Shared on February 5, 2011 at 12:02 am By:
Gannett Healthcare Health News
Breaking News: FDA Warns of Cancer Threat, Calls for Breast Implant Labeling Change http://tinyurl.com/4lzc7oz
Lilly Halts Melanoma Trial Following Subject Deaths
fdanews.com — “Eli Lilly has put a global Phase III trial of its melanoma drug tasisulam on full clinical hold after several subjects died.” View full resource at fdanews.com
Most Recently Shared on January 14, 2011 at 11:20 am By:
Evan Lipson Oncology, Physician, Doctor, and Internist
Lilly halts #melanoma trial of tasisulam following subject deaths http://bit.ly/gvJKaJ
NCI, CDISC Plan to Launch Electronic Library for Data
fdanews.com — “A new initiative has been launched between the National Cancer Institute (NCI) and the Clinical Data Interchange Standards Consortium (CDISC) to develop an electronic library that would include multidimensional, machine-readable clinical study metadata.” View full resource at fdanews.com
Most Recently Shared on November 16, 2010 at 4:32 pm By:
NCI, CDISC Plan to Launch Electronic Library for Data (summary only) http://goo.gl/K03LP
ISMP Recommends FDA Investigate Tylenol Recalls
fdanews.com — “The Institute for Safe Medication Practices (ISMP), a nonprofit drug safety organization, wants the FDA to ensure there is an objective investigation into recent Tylenol recalls and contamination issues.” View full resource at fdanews.com
Most Recently Shared on November 12, 2010 at 10:10 pm By:
ISMP recommendations to FDA investigation of Tylenol recall http://bit.ly/aMgW3m
