FDA Adopts Interim Plan to Avoid Shortage of Medically Necessary Opioid
The U.S Food and Drug Administration today amended its March 30, 2009, action warning manufacturers to stop the production and distribution of certain unapproved prescription opioids, to allow the continued marketing and distribution of one particular type of opioid -- a high concentrate morphine sulfate oral solution -- on an interim basis.

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DCS and NextDocs Partner to Deliver Compliance Without Complexity (Business Wire via Yahoo! Finance)
PHILADELPHIA----DCS Hosted Solutions has formed a key alliance with NextDocs Corporation to make it easier for small companies in the life sciences industry to achieve their goals, collaborate with partners, and bring products and services to market earlier.

Novo Nordisk A/S -- 1st Quarter Results (Marketwire)
BAGSVAERD, DENMARK--(Marketwire - April 30, 2009) - Interim financial report for the period 1 January 2009 to 31 March 2009 Novo Nordisk increased sales by 18% in the first quarter of 2009 Operating profit increased by 35% supported by continued gross margin improvement * Sales in Danish kroner increased by 18% and by 11% in local currencies. o Sales of modern insulins increased by 31% (25% in ...

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FDA Authorizes Emergency Use Of Influenza Medicines, Diagnostic Test In Response To Swine Flu Outbreak In Humans (Medical News Today)
The U.S. Food and Drug Administration, in response to requests from the U.S. Centers for Disease Control and Prevention, has issued Emergency Use Authorizations (EUAs) to make available to public health and medical personnel important diagnostic and therapeutic tools to identify and respond to the swine flu virus under certain circumstances.

FDA Requires Additional Labeling For Over-the-Counter Pain Relievers And Fever Reducers To Help Consumers Use Products ... (Medical News Today)
The Food and Drug Administration issued a final rule today that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labeling to include warnings about potential safety risks, such as internal bleeding and liver damage, associated with the use of these popular drugs.

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FDA Accepts For Review Theravance's Complete Response Submission For Telavancin For The Treatment Of Complicated Skin ... (Medical News Today)
Theravance, Inc. (NASDAQ: THRX) announced that the U.S. Food and Drug Administration (FDA) accepted as complete for review Theravance's response to the February 2009 Complete Response letter, which outlined requirements for approval of telavancin for the treatment of complicated skin and skin structure infections (cSSSI).

Editorials Commend FDA Decision To Expand Access To Plan B Emergency Contraception (Medical News Today)
Two newspapers recently published editorials responding to the FDA's decision to lower the age limit for nonprescription sale of the emergency contraceptive Plan B from age 18 to age 17. Summaries appear below.~ Baltimore Sun: FDA's decision to expand nonprescription sales of Plan B to women 17 or older "was a long-overdue triumph of science over politics," a Sun editorial states.

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FDA Acts to Halt Marketing of Certain Unapproved Prescription Narcotic Drugs
The U.S. Food and Drug Administration today warned nine companies to stop manufacturing 14 unapproved narcotic drugs that are marketed in several dosage forms and are widely used to treat pain.

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Interest in birth control measures up (Wausau Daily Herald)
Couples might be hitting the sack instead of the shops during the recession, but they appear to be taking precautions, too. Vasectomies increased 30 percent the first three months of 2009 over the same period in 2008 at Urology Specialists of Wisconsin in Wausau, while interest in longer-term birth control methods for women appears to be growing at Family Planning Health Services, Inc.

Under-age sex laws 'putting NT kids at risk' (Australian Broadcasting Corporation)
The Australian Medical Association (AMA) is warning that legislative changes in the Northern Territory could have a devastating impact on the health of many Indigenous children.

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Carotid WALLSTENT® Monorail® Endoprosthesis
The Carotid WALLSTENT ® Monorail ® Endoprosthesis is an implant used to re-open narrowed (stenotic) regions of the carotid arteries in the neck which supply blood to the brain. This device consists of the stent and a stent delivery system... (Approved: 10/23/2008)

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Brent and Sam's Issues Allergy Alert on Undeclared Pecans in Simply Enjoy Pina Colada White Chocolate Gourmet Cookies (April 23)
North Little Rock-based Brent and Sam's announced today a voluntary recall on 31 cases of Simply Enjoy Brand Pina Coloda White Chocolate Gourmet Cookies because it may contain undeclared pecans. People who have an allergy or severe sensitivity to tree nuts(pecans) run the risk of serious or life threatening allergic reaction if they consume this product.

Setton International Foods, Inc. Clarifies Product and Identification Codes of Recalled Products (April 27)
Setton International Foods, Inc., today issued a clarification to its wholesale customers regarding the product and identification codes for bulk and packaged pistachio products that contain pistachios manufactured by Setton Pistachio of Terra Bella, Inc. which were recalled on April 3, 2009 and April 14, 2009 to ensure that there is no misunderstanding about the covered product and identification codes.

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FDA Researchers Contribute Insights into Avian Flu Virus
An in-depth analysis of blood from patients recovering from the H5N1 avian influenza virus has provided important insights into how to combat the potentially lethal virus.

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FDA Accepts For Review Theravance's Complete Response Submission For Telavancin For The Treatment Of Complicated Skin ... (Medical News Today)
Theravance, Inc. (NASDAQ: THRX) announced that the U.S. Food and Drug Administration (FDA) accepted as complete for review Theravance's response to the February 2009 Complete Response letter, which outlined requirements for approval of telavancin for the treatment of complicated skin and skin structure infections (cSSSI).

OncoGenex Receives Confirmation from FDA on the Design of a Second Phase 3 Trial (T-Net British Columbia)
Vancouver, BC, April 28, 2009--(T-Net)--OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today that the company has reached an agreement with the U.S. Food and Drug Administration on the design of a second Phase 3 registration trial of OGX-011, its lead product candidate targeting castrate resistant prostate cancer, via the Special Protocol Assessment process.

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FDA Approves Coartem Tablets to Treat Malaria
The U.S. Food and Drug Administration has approved Coartem tablets (artemether and lumefantrine) for the treatment of acute, uncomplicated malaria infections in adults and children weighing at least five kilograms (approximately 11 pounds).

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Safe use of methadone is urged (UPI)
WASHINGTON, April 28 (UPI) -- Federal officials say they have started a program designed to ensure the safe use of methadone, a prescription drug used to treat heroin addiction.

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Updated FDA Action On Plan B (levonorgestrel) Tablets (Medical News Today)
On March 23, 2009, a federal court issued an order directing the FDA, within 30 days, to permit the Plan B drug sponsor to make Plan B available to women 17 and older without a prescription. The government will not appeal this decision.

FDA To Allow Sale Of Plan B Emergency Contraception To 17-Year-Olds (Medical News Today)
FDA on Wednesday announced that it will allow the non-prescription sale of the emergency contraceptive Plan B to individuals ages 17 years and older, in compliance with a federal judge's March 23 ruling that the agency's 2006 decision to limit access to women ages 18 and older was politically motivated and scientifically flawed, the Washington Post reports. U.S.

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FDA Gives Clinical Trial Green Light On Drug To Treat Alzheimer's Disease (Medical News Today)
The Food and Drug Administration (FDA) has given the Blanchette Rockefeller Neurosciences Institute (BRNI) the go-ahead to conduct Phase II clinical trials of Bryostatin for the treatment of Alzheimer's disease patients. The drug showed pre-clinical efficacy to not only treat Alzheimer's disease symptoms, but also its underlying causes.

FDA To Allow Sale Of Plan B Emergency Contraception To 17-Year-Olds (Medical News Today)
FDA on Wednesday announced that it will allow the non-prescription sale of the emergency contraceptive Plan B to individuals ages 17 years and older, in compliance with a federal judge's March 23 ruling that the agency's 2006 decision to limit access to women ages 18 and older was politically motivated and scientifically flawed, the Washington Post reports. U.S.

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FDA Approves Coartem Tablets to Treat Malaria
The U.S. Food and Drug Administration has approved Coartem tablets (artemether and lumefantrine) for the treatment of acute, uncomplicated malaria infections in adults and children weighing at least five kilograms (approximately 11 pounds).

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FDA Approves Benzyl Alcohol Lotion for the Treatment of Head Lice
The U.S. Food and Drug Administration today approved a new prescription medication for the treatment of head lice ( Pediculosis capitis ) infestation. Benzyl Alcohol Lotion, 5 Percent, received full market approval as a prescription medication, for use in patients 6 months of age and older.

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FDA relaxes prior notice rule for food imports (Food Navigator USA)
The guide, entitled What You Need To Know About Prior Notice of Imported Food Shipments: A Small Entity Compliance Guide , provides an update on the prior notice interim final rule issued under the 2002 Bioterrorism Act, which was published in the Federal Register in November, after it was discovered that it would prove too costly for small companies.

FDA To Allow Sale Of Plan B Emergency Contraception To 17-Year-Olds (Medical News Today)
FDA on Wednesday announced that it will allow the non-prescription sale of the emergency contraceptive Plan B to individuals ages 17 years and older, in compliance with a federal judge's March 23 ruling that the agency's 2006 decision to limit access to women ages 18 and older was politically motivated and scientifically flawed, the Washington Post reports. U.S.

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FDA Researchers Contribute Insights Into Avian Flu Virus (Medical News Today)
An in-depth analysis of blood from patients recovering from the H5N1 avian influenza virus has provided important insights into how to combat the potentially lethal virus. The findings by U.S. Food and Drug Administration scientists and collaborators better explain what part of the "bird flu" virus is seen by the immune system once a person becomes infected.

FDA Fails To Consider Risks Of Over The Counter Plan B (Medical News Today)
Moira Gaul, Family Research Council's Director of Women's and Reproductive Health, released the following statement regarding the Obama Administration's decision to sell the morning-after-pill to 17-year-olds without a prescription. "The Obama Administration is permitting a judge to make a scientific decision as to the safety of the over-the-counter sale of Plan B.

FDA Gives Clinical Trial Green Light On Drug To Treat Alzheimer's Disease (Medical News Today)
The Food and Drug Administration (FDA) has given the Blanchette Rockefeller Neurosciences Institute (BRNI) the go-ahead to conduct Phase II clinical trials of Bryostatin for the treatment of Alzheimer's disease patients. The drug showed pre-clinical efficacy to not only treat Alzheimer's disease symptoms, but also its underlying causes.

Read more about FDA Approvals - FDA Researchers Contribute Insights Into Avian Flu Virus (Medical News

FDA Alerts the Public to Uncle Chen and Lian How Brand Dry Spice Product Recall
The U.S. Food and Drug Administration (FDA) is alerting the public to a voluntary recall by Union International Food Company (Union City, Calif.) of the company's dry spice products. The recall is based on an investigation of an ongoing foodborne illness outbreak of Salmonella Rissen. This investigation is being conducted in collaboration with state health officials in California, Oregon, Nevada, Washington and the U.S. Centers for Disease Control and Prevention (CDC). The company's products are distributed in these states and Arizona.

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Birth control numbers up, doctors say (Wausau Daily Herald)
Couples might be hitting the sack instead of the shopping mall during the recession, but they appear to be taking precautions, too.

Schering-Plough Reports Financial Results for 2009 First Quarter (PR Newswire via Yahoo! Finance)
Leading Late-Stage Pipeline

Interest in birth control measures up (Wausau Daily Herald)
Couples might be hitting the sack instead of the shops during the recession, but they appear to be taking precautions, too. Vasectomies increased 30 percent the first three months of 2009 over the same period in 2008 at Urology Specialists of Wisconsin in Wausau, while interest in longer-term birth control methods for women appears to be growing at Family Planning Health Services, Inc.

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