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FDA releases GDUFA draft guidance

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration has released draft guidance for the Generic Drug User Fee Amendments to the Prescription Drug User Fee Act, the agency said.

A collection of documents posted on the FDA’s website includes guidance for the generic drug industry on self-identification of generic drug facilities, sites and organizations, questions and answers about the draft guidance and others.

The amendments, part of the renewal of PDUFA that president Barack Obama signed in July, will $299 million per year in user fees from generic drug companies over the next five years starting on Oct. 1. This, drug makers and agency officials hope, will help the FDA reduce a backlog of about 2,500 generic drug approval applications and ensure faster review of future applications.


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Walmart takes a shot at expanding healthcare access

BY Mike Troy

BENTONVILLE, Ark. — The nation’s largest retailer is expanding an in-store healthcare initiative involving 10 types of immunizations administered at its stores through Nov. 15.

Walmart said it is working with Mollen Immunization Clinics to provide 10 of the immunizations recommended by the Centers for Disease Control and Prevention at 2,700 stores. In addition, the company said flu and pneumonia vaccines would be available at all 3,800 stores with pharmacies.

Walmart said it is the first national retailer to use registered nurses to administer in-store vaccinations across all store locations and will also provide free blood pressure screenings at immunization events held on September 8, 15, 22 and 29.

"According to the Centers for Disease Control and Prevention, many adults are not up-to-date with recommended life-saving immunizations. Vaccinations may not be top-of-mind while the weather is still warm, but they are a critical part of public health, especially in light of recent outbreaks of whooping cough and shingles," said John Agwunobi, M.D., president of Walmart U.S. Health and Wellness. "We are making it easy and affordable for our customers to receive their vaccinations, while on their normal shopping trips they can simply stop by immunization events, which will accept thousands of insurance plans and offer low price options for our cash paying customers."

Vaccinations offered include: Flu, Pneumonia, Hepatitis A and B, Chickenpox, HPV, MMR, Menigitis, Shingles and Tetanus.

The company said the immunization events are part of its effort to provide customers with better access to quality, affordable healthcare. Medicare Part B as well as thousands of insurance plans will be accepted at these events. The retailer’s partner on the program, Mollen Immunization Clinics, last year employed 30,000 nurses who administered 165,000 immunizations.

Hours vary by store with details available at Walmart.com/flushots.

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Walmart takes a shot at expanding healthcare access

BY DSN STAFF

BENTONVILLE, Ark. — The nation’s largest retailer is expanding an in-store healthcare initiative involving 10 types of immunizations administered at its stores through Nov. 15.

Walmart said it is working with Mollen Immunization Clinics to provide 10 of the immunizations recommended by the Centers for Disease Control and Prevention at 2,700 stores. In addition, the company said flu and pneumonia vaccines would be available at all 3,800 stores with pharmacies.

Walmart said it is the first national retailer to use registered nurses to administer in-store vaccinations across all store locations and will also provide free blood pressure screenings at immunization events held on September 8, 15, 22 and 29.

"According to the Centers for Disease Control and Prevention, many adults are not up-to-date with recommended life-saving immunizations. Vaccinations may not be top-of-mind while the weather is still warm, but they are a critical part of public health, especially in light of recent outbreaks of whooping cough and shingles," said John Agwunobi, M.D., president of Walmart U.S. Health and Wellness. "We are making it easy and affordable for our customers to receive their vaccinations, while on their normal shopping trips they can simply stop by immunization events, which will accept thousands of insurance plans and offer low price options for our cash paying customers."

Vaccinations offered include: Flu, Pneumonia, Hepatitis A and B, Chickenpox, HPV, MMR, Menigitis, Shingles and Tetanus.

The company said the immunization events are part of its effort to provide customers with better access to quality, affordable healthcare. Medicare Part B as well as thousands of insurance plans will be accepted at these events. The retailer’s partner on the program, Mollen Immunization Clinics, last year employed 30,000 nurses who administered 165,000 immunizations.

Hours vary by store with details available at Walmart.com/flushots.

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