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May 9, 2013

One of the difficulties that federal regulators ran into during the nationwide scandal surrounding the New England Compounding Center — the Massachusetts-based pharmacy blamed for a nationwide fungal meningitis epidemic that has sickened hundreds and killed dozens — was the issue of when such pharmacies cross the line from compounding to manufacturing.

WASHINGTON — One of the difficulties that federal regulators ran into during the nationwide scandal surrounding the New England Compounding Center — the Massachusetts-based pharmacy blamed for a nationwide fungal meningitis epidemic that has sickened hundreds and killed dozens — was the issue of when such pharmacies cross the line from compounding to manufacturing.

April 17, 2013

Food and Drug Administration commissioner Margaret Hamburg faced strong criticism Tuesday in a hearing before the House Committee on Energy and Commerce to investigate the nationwide outbreak of fungal meningitis linked to a Massachusetts compounding pharmacy, but she conceded the agency could have done more.

WASHINGTON — Food and Drug Administration commissioner Margaret Hamburg faced strong criticism Tuesday in a hearing before the House Committee on Energy and Commerce to investigate the nationwide outbreak of fungal meningitis linked to a Massachusetts compounding pharmacy, but she conceded the agency could have done more.

April 12, 2013

An inspection of more than two-dozen compounding pharmacies by Food and Drug Administration officials has found widespread problems with sanitation and sterilization practices, FDA commissioner Margaret Hamburg wrote in a blog post on the agency's website Thursday.

SILVER SPRING, Md. — An inspection of more than two-dozen compounding pharmacies by Food and Drug Administration officials has found widespread problems with sanitation and sterilization practices, FDA commissioner Margaret Hamburg wrote in a blog post on the agency's website Thursday.

April 5, 2013

The Food and Drug Administration has 30 days to approve over-the-counter availability of the emergency contraceptive Plan B One-Step to women of all ages, according to a decision issued by Judge Edward Korman of the U.S. District Court, Eastern District of New York.

NEW YORK — The Food and Drug Administration has 30 days to approve over-the-counter availability of the emergency contraceptive Plan B One-Step to women of all ages, according to a decision issued Friday by Judge Edward Korman of the United States District Court, Eastern District of New York. In a second decision, Korman declined to intervene on Teva Pharma's behalf in extending patent exclusivity for Plan B One-Step. 

March 22, 2013

The commissioner of the Food and Drug Administration is renewing calls for legislation to give the agency more authority to regulate pharmacy compounding.

SILVER SPRING, Md. — The commissioner of the Food and Drug Administration is renewing calls for legislation to give the agency more authority to regulate pharmacy compounding.

March 20, 2013

A group of doctors and public health professors are hoping the Food and Drug Administration will place stronger regulations on energy drinks to protect children and adolescents from what they call the harmful effects of high caffeine consumption.

NEW YORK — A group of doctors and public health professors are hoping the Food and Drug Administration will place stronger regulations on energy drinks to protect children and adolescents from what they call the harmful effects of high caffeine consumption.

March 12, 2013

The attorneys general of 46 states and two territories are calling on the Food and Drug Administration to make prescription painkillers harder to abuse.

NEW YORK — The attorneys general of 46 states and two territories are calling on the Food and Drug Administration to make prescription painkillers harder to abuse.

February 22, 2013

One of the FDA's chief duties is ensuring the quality of food and drug products, and that was the focus of a keynote address delivered at the GPhA annual meeting.

NEW YORK — One of the Food and Drug Administration's chief duties is ensuring the quality of food and drug products, and that was the focus of a keynote address delivered Friday morning by FDA commissioner Margaret Hamburg at the Generic Pharmaceutical Association's annual meeting.

In the address, viewed via webcast, Hamburg addressed issues ranging from quality to drug shortages to follow-on biologics, praising the generics industry's role in contributing more than $1 trillion in savings to the healthcare system over the past decade.

January 30, 2013

A ban on importing and selling animal-tested cosmetics products and ingredients will enter into force in March. The ban affects all cosmetics, including toiletries and beauty products.

LONDON — A ban on importing and selling animal-tested cosmetics products and ingredients will enter into force in March. The ban affects all cosmetics, including toiletries and beauty products.

"I believe that the ban should enter into force in March 2013 as Parliament and Council already have decided. I therefore am not planning to propose a postponement or derogation to the ban," Commissioner Tonio Borg wrote in a recent letter to animal testing campaigners.

January 22, 2013

The Food and Drug Administration on Friday approved the distribution of 2 million additional doses of Tamiflu (oseltamivir phosphate) 75 mg that contain an older version of the package insert.

ATLANTA — The Food and Drug Administration on Friday approved the distribution of 2 million additional doses of Tamiflu (oseltamivir phosphate) 75 mg that contain an older version of the package insert.

January 16, 2013

New York is hoping to battle the theft of highly addictive prescription drugs, such as Oxycontin, by stocking pharmacies with fake pill bottles that are fitted with GPS tracking devices, according to published reports.

NEW YORK — New York is hoping to battle the theft of highly addictive prescription drugs, such as Oxycontin, by stocking pharmacies with fake pill bottles that are fitted with GPS tracking devices, according to published reports.

The Washington Post reported that Police Commissioner Raymond Kelly said, in prepared remarks provided before a conference Tuesday in California sponsored by former president Bill Clinton’s foundation, that the initiative was sparked by a series of crimes associated with the black market for prescription painkillers.

December 20, 2012

An advocacy group said proposed Food and Drug Administration rules for compounding pharmacies would put the public's health and safety at risk.

WASHINGTON — An advocacy group said proposed Food and Drug Administration rules for compounding pharmacies would put the public's health and safety at risk.

In a letter sent to Department of Health and Human Services secretary Kathleen Sebelius, Public Citizen criticized Food and Drug Administration commissioner Margaret Hamburg for "both undermining her agency's authority in congressional testimony last month and offering a plan that would effectively weaken the agency's oversight of drug manufacturing."

December 11, 2012

The New York Department of Health on Monday announced that reported cases of influenza are increasing throughout New York, and flu activity in the state is now considered to be widespread, with laboratory-confirmed cases in more than half the regions.

ALBANY — The New York Department of Health on Monday announced that reported cases of influenza are increasing throughout New York, and flu activity in the state is now considered to be widespread, with laboratory-confirmed cases in more than half the regions. 

Since New York began its annual seasonal flu surveillance this fall, influenza cases have been reported in 47 counties and the five boroughs of New York City. This is consistent with nationwide reporting that shows influenza activity is also increasing in many regions of the country. 

November 28, 2012

The Food and Drug Administration will review the safety of energy drinks containing such stimulants as caffeine in response to a letter from two senators.

WASHINGTON — The Food and Drug Administration will review the safety of energy drinks containing such stimulants as caffeine in response to a letter from two senators.

November 14, 2012

Food and Drug Administration commissioner Margaret Hamburg is asking Congress to give the agency more power to regulate compounding pharmacies amid a national meningitis outbreak linked to a Massachusetts-based compounding pharmacy that has claimed dozens of lives nationwide.

NEW YORK — Food and Drug Administration commissioner Margaret Hamburg is asking Congress to give the agency more power to regulate compounding pharmacies amid a nationwide meningitis outbreak linked to a Massachusetts-based compounding pharmacy that has claimed dozens of lives nationwide.

October 25, 2012

New York City Mayor Michael Bloomberg and Health Commissioner Thomas Farley received their seasonal flu vaccination Thursday morning at a Duane Reade pharmacy in New York City, demonstrating the importance of taking proactive steps to prevent the spread of influenza.

NEW YORK CITY — New York City Mayor Michael Bloomberg and Health Commissioner Thomas Farley received their seasonal flu vaccination Thursday morning at a Duane Reade pharmacy in New York City, demonstrating the importance of taking proactive steps to prevent the spread of influenza.

October 15, 2012

The Food and Drug Administration may be willing to speed up trials for drugs that could be a big benefit to society despite their risks.

SILVER SPRING, M.D. — The Food and Drug Administration may be willing to speed up trials for drugs that could be a big benefit to society despite their risks.

According to several published reports, FDA commissioner Margaret Hamburg recently told a group of scientific advisers that the agency is considering allowing makers of drugs having a societal benefit to conduct faster clinical trials with a smaller group of patients than is now required.

October 9, 2012

The New York City health commissioner’s ban on the sale of big cups of fountain soda drew many an unfavorable accusation that the administration of mayor Michael Bloomberg was trying to turn the city into a nanny state, with NaturalNews.com editor Mike Adams asking, “What’s next? Is Bloomberg gonna pull a Singapore and ban chewing gum too?”


The New York City health commissioner’s ban on the sale of big cups of fountain soda drew many an unfavorable accusation that the administration of mayor Michael Bloomberg was trying to turn the city into a nanny state, with NaturalNews.com editor Mike Adams asking, “What’s next? Is Bloomberg gonna pull a Singapore and ban chewing gum too?”


October 5, 2012

In partnership with international regulatory and law enforcement agencies, the Food and Drug Administration on Thursday announced it had taken action against more than 4,100 Internet pharmacies that illegally sell unapproved drugs to consumers.

SILVER SPRING, Md. — In partnership with international regulatory and law enforcement agencies, the Food and Drug Administration on Thursday announced it had taken action against more than 4,100 Internet pharmacies that illegally sell unapproved drugs to consumers. Actions taken include civil and criminal charges, seizure of illegal products and removal of offending websites.

September 28, 2012

Keynote speeches by pharmaceutical industry and regulatory leaders got top billing as more than 140 government, healthcare industry, law enforcement and patient advocacy officials gathered to find ways to combat the spread of counterfeit medicines.

WASHINGTON — Keynote speeches by pharmaceutical industry and regulatory leaders got top billing as more than 140 government, healthcare industry, law enforcement and patient advocacy officials gathered to find ways to combat the spread of counterfeit medicines.

August 10, 2012

Walgreens on Saturday will be hosting its first Mobile Photo Hack Day — a contest among mobile photo application developers in creating a "groundbreaking" application using Walgreens' QuickPrints SDK.

CHICAGO — Walgreens on Saturday will be hosting its first Mobile Photo Hack Day — a contest among mobile photo application developers in creating a "groundbreaking" application using Walgreens' QuickPrints SDK.

All entries will be reviewed by a panel of notable judges:

  • Kobie Hatcher, solutions director at AIM Consulting, a technology solutions and services company providing resources in flexible configurations;

May 16, 2012

A consumer group is urging the Food and Drug Administration to review a proprietary point-of-purchase nutrition rating system that it said is "inconsistent with FDA guidance statements and enforcement correspondence, federal nutrition programs and recommendations from the Institute of Medicine."

WASHINGTON — A consumer group is urging the Food and Drug Administration to review a proprietary point-of-purchase nutrition rating system that it said is "inconsistent with FDA guidance statements and enforcement correspondence, federal nutrition programs and recommendations from the Institute of Medicine."

May 11, 2012

There is an important distinction to be made here, one that could place pharmacy operators and over-the-counter manufacturers on opposite sides of the aisle.

WHAT IT MEANS AND WHY IT'S IMPORTANT — There is an important distinction to be made here, one that could place pharmacy operators and over-the-counter manufacturers on opposite sides of the aisle. And that's the call for a codified third class of drugs, made more or less by both the National Association of Chain Drug Stores and the National Community Pharmacists Association in their written submissions to the Food and Drug Administration on expanding the switch paradigm.

May 4, 2012

The number of new drug shortages has been halved as early notifications from manufacturers of potential shortages have increased sixfold, the commissioner of the Food and Drug Administration wrote Thursday.

SILVER SPRING, Md. — The number of new drug shortages has been halved as early notifications from manufacturers of potential shortages have increased sixfold, the commissioner of the Food and Drug Administration wrote Thursday.

April 2, 2012

“Straight over the cliff.” That may be the destination for many independent pharmacies now that the Federal Trade Commission has unconditionally approved the controversial merger of the nation’s second- and third-largest pharmacy benefit managers, a top pharmacy leader warned.

“Straight over the cliff.”

That may be the destination for many independent pharmacies now that the Federal Trade Commission unconditionally has approved the controversial merger of the nation’s second- and third-largest pharmacy benefit managers, a top pharmacy leader warned.