Recent News & Articles
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FDA Approval2010-01-26 - FDA Approves Morphine Sulfate Oral Solution for Relief of Acute and Chronic Pain
The U.S. Food and Drug Administration today approved Morphine Sulfate Oral Solution for the relief of moderate to severe, acute and chronic pain in opioid-tolerant patients. This medicine will be available in 100 milligrams per 5 mL or 20 milligrams ...
FDA
2010-01-26 - Velcade (bortezomib): Starting Dose Adjustments for Patients with Hepatic Impairment
Takeda Oncology and FDA notified healthcare professionals about revisions to the Prescribing Information for Velcade, section 2.5, pertaining to patients with hepatic impairment at the start of Velcade therapy.
FDA
2010-01-26 - Velcade (bortezomib): Starting Dose Adjustments for Patients with Hepatic Impairment
Takeda Oncology and FDA notified healthcare professionals about revisions to the Prescribing Information for Velcade, section 2.5, pertaining to patients with hepatic impairment at the start of Velcade therapy.
PQRI Standards for Oncology
2010-01-21 - PQRI 2010 Standards for Oncology
FDA Approval
2009-09-28 - Pralatrexate Injection (Folotyn)
: On September 24, 2009, the Office of Oncology Drug Products granted accelerated approval to pralatrexate injection (FOLOTYN, Allos Therapeutics, Inc.) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). Th...
FDA
2009-09-16 - FDA Clears a Test for Ovarian Cancer
FDA Clears a Test for Ovarian Cancer
Test can help identify potential malignancies, guide surgical decisions
The U.S. Food and Drug Administration today cleared a test that can help detect ovarian cancer in a pelvic mass that is already known to ...
Test can help identify potential malignancies, guide surgical decisions
The U.S. Food and Drug Administration today cleared a test that can help detect ovarian cancer in a pelvic mass that is already known to ...
FDA
2009-09-16 - FDA Requires Boxed Warning for Promethazine Hydrochloride Injection
FDA Requires Boxed Warning for Promethazine Hydrochloride Injection
The U.S. Food and Drug Administration is telling manufacturers of the drug promethazine to include a boxed warning regarding the injectable form of the drug. The warning, under FDA'...
The U.S. Food and Drug Administration is telling manufacturers of the drug promethazine to include a boxed warning regarding the injectable form of the drug. The warning, under FDA'...
FDA
2009-08-21 - FDA Issues Final Rules to Help Patients Gain Access to Investigational Drugs
The U.S. Food and Drug Administration published two rules today that seek to clarify the methods available to seriously ill patients interested in gaining access to investigational drugs and biologics when they are not eligible to participate in a cl...
Medicare
2009-08-21 - Reporting Non-Tax Withholding Due to Federal Payment Levy Program (FPLP)
Reporting Non-Tax Withholding Due to Federal Payment Levy Program (FPLP)
Reference: Trans. 503, CR #6228, Pub. 100-20, MLN: MM6228
Published Online: 8/14/2009
Provider Types Affected
Physicians and providers who bill Medicare carriers, fiscal i...
Reference: Trans. 503, CR #6228, Pub. 100-20, MLN: MM6228
Published Online: 8/14/2009
Provider Types Affected
Physicians and providers who bill Medicare carriers, fiscal i...
Health Care
2009-08-21 - Reporting Non-Tax Withholding Due to Federal Payment Levy Program (FPLP)
By JONATHAN WEISMAN and NAFTALI BENDAVID
The White House and Senate Democratic leaders, seeing little chance of bipartisan support for their health-care overhaul, are considering a strategy shift that would break the legislation into two parts and p...
The White House and Senate Democratic leaders, seeing little chance of bipartisan support for their health-care overhaul, are considering a strategy shift that would break the legislation into two parts and p...
CMS Update
2009-08-07 - updated policy from CMS regarding OncotypeDX- J1 MAC
http://www.cms.hhs.gov/mcd/viewlcd.asp?lcd_id=28287&lcd_version=18&show=
FDA Approval
2009-07-31 - FDA Approval for Avastin in Combination with Interferon Alfa
Bevacizumab (Avastin) in Combination with Interferon Alfa
On July 31, 2009 the U.S. Food and Drug Administration granted approval for the use of bevacizumab (Avastin, Genentech, Inc.) in combination with interferon alfa for the treatment of patients...
On July 31, 2009 the U.S. Food and Drug Administration granted approval for the use of bevacizumab (Avastin, Genentech, Inc.) in combination with interferon alfa for the treatment of patients...
FDA Approval
2009-07-16 - Opioid Fentanyl
FDA Approves Opioid Pain Reliever with Required Risk Reduction Plan The U.S. Food and Drug Administration today approved Onsolis, medication intended for certain patients with cancer to help manage breakthrough pain - severe flares of pain that break...
FDA Approval
2009-07-09 - FDA Approves First Maintenance Drug Therapy for Advanced Lung Cancer(Alimta)
FDA Approves First Maintenance Drug Therapy for Advanced Lung Cancer
The U.S. Food and Drug Administration has approved Alimta (pemetrexed), the first drug available for maintenance therapy of advanced or metastatic lung cancer.
The U.S. Food and Drug Administration has approved Alimta (pemetrexed), the first drug available for maintenance therapy of advanced or metastatic lung cancer.
FDA Approval
2009-07-02 - Ferumoxytol (Feraheme) Injection
The safety and efficacy of ferumoxytol in the episodic treatment of iron deficiency anemia were assessed in three randomized, open-label, controlled clinical trials enrolling approximately 800 patients with CKD. In all three controlled trials, patie...
CMS Update
2009-07-02 - Medicare Issues Severe Cuts for Community Oncology
CMS has just issued severe cuts to Medicare reimbursement, including a 6% payment cut for community cancer care and elimination of consultation codes.
The CMS cut to cancer care is based upon the flawed survey data provided to
CMS by the AMA, whic...
The CMS cut to cancer care is based upon the flawed survey data provided to
CMS by the AMA, whic...
FDA
2009-05-21 - Drug Shortages Updates
Morphine Sulfate Oral Solution updated by FDA 5/20/2009
Roxane Laboratories (20mg/5ml and 10mg/5ml) - has product available
Mallinckrodt Inc. (20mg/ml) Customer Service number (1-800-325-8888) - increased demand due to another manufacturer leav...
Roxane Laboratories (20mg/5ml and 10mg/5ml) - has product available
Mallinckrodt Inc. (20mg/ml) Customer Service number (1-800-325-8888) - increased demand due to another manufacturer leav...
FDA
2009-05-18 - Drug Shortages
Oplinc
2009-05-15 - Oplinc Newsletter
CORRECTION - CORRECTED EFFECTIVE DATE FOR CLINICAL PHARMACOLOGY COMPENDIA this week's Oplinc Fast Facts should have identified the effective date of July 2, 2008 for the Clinical Pharmacology Compendia. Please disregad the earlier issue and reference...
FDA
2009-05-11 - FDA MedWatch - Tarceva
FDA MedWatch - Tarceva
FDA Approval
2009-05-08 - Avastin for Glioblastoma
FDA Approves Drug for Treatment of Aggressive Brain Cancer
The U.S. Food and Drug Administration recently approved Avastin (bevacizumab) to treat patients with glioblastoma multiforme (GBM) when this form of brain cancer continues to progress follow...
The U.S. Food and Drug Administration recently approved Avastin (bevacizumab) to treat patients with glioblastoma multiforme (GBM) when this form of brain cancer continues to progress follow...