The Pharma Data

JUNE 18, 2021

Food and Drug Administration (FDA) has approved PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine) for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older. Following today’s FDA approval, the U.S.

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Agency IQ

JUNE 7, 2024

These products are also required to comply with certain labeling expectations and manufacturers are expected to follow a specific set of current good manufacturing practices ( a final rule issued in 2007). Dietary supplement products do not need approval prior to being marketed – unless they contain a new dietary ingredient (NDI).

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The Pharma Data

MAY 16, 2021

Plus, many of these kits claimed to be EU or FDA approved, when they were anything but… Quite simply, they were ILLEGAL, but I was still able to buy them online – and so can you. s one from The Daily Mail in the UK, which was highlighting the risks all the way back in 2007… And very little has changed since then!

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Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. The FDA maintains a webpage with the full rulemaking history for OTC nasal decongestant drug products.

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Agency IQ

MARCH 7, 2024

Next: Enriched Enrollment, Randomized Withdrawal (EERW) clinical trial designs. As AgencyIQ has previously discussed , the Tropical Disease PRV program was actually the first of FDA’s voucher programs, introduced in 2007 to incentivize the development of products to treat diseases (i.e.,

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Advarra

DECEMBER 14, 2022

Effective as of 2007, Medicare has offered coverage for routine costs in clinical trials. However, in order to be eligible for extended coverage under a clinical trial, several requirements must be met. Clinical trial agreement. If an MCA is required, does this clinical trial qualify for Medicare coverage?

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Drug & Device Law

FEBRUARY 22, 2024

This “keep selling” theory found some traction in two 2007 decisions, Abigail Alliance for Better Access to Developmental Drugs v. 2007) (en banc), and CareToLive v. Ohio 2007), but has generally failed to expand that foothold since. von Eschenbach , 495 F.3d 3d 695 (D.C. von Eschenbach , 525 F. 2d 952 (S.D.

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