Containment FDA Approval Packaging Regulation 
XTalks
JULY 27, 2023
Last week, the US Food and Drug Administration (FDA) stood by its decision, denying a petition asking it to reevaluate the use of eight ortho-phthalates in food-contacting packaging materials. Related: Is Fiber Based Packaging the Next Trend in Sustainable Food Packaging?
XTalks
JULY 27, 2022
Yet over the past few weeks, she’s faced numerous questions about Pink Sauce’s ingredients, packaging and marketing, prompting a social media-based food scandal. He showed the bottle label that seemed to indicate that it contains 444 servings of the product, at 60 calories per serving of about a tablespoon — a near mathematical impossibility.
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XTalks
FEBRUARY 8, 2024
Ozempic (Semaglutide) Ozempic sales in 2022: $8.713 billion Company/Developer: Novo Nordisk Date of first FDA approval: December 5, 2017 Indications Ozempic is FDA-approved for: Type 2 diabetes Price of Ozempic: $1,029 for 1.5 Read on to learn more about the top 15 diabetes drugs in 2023, based on 2022 sales statistics.
Camargo
NOVEMBER 15, 2021
In October, the FDA took a step towards clarifying these questions with a guidance called “ Data Standards for Drug and Biological Product Submissions Containing Real-World Data.”. The guidance also contains some useful information, despite the limitations described above.
Advarra
JULY 19, 2022
The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. A: This is a complex topic and is best outlined in the FDA’s guidance document. Q: What is the typical time period between the submission of the briefing package and the pre-IND meeting?
FDA Law Blog
AUGUST 17, 2023
This statutory provision requires generic drugs to have the same labeling as that approved for the listed drug “except for changes required because of differences approved under a [suitability petition, allowing for certain differences] or because the new drug and the listed drug are produced or distributed by different manufacturers.”
Camargo
JUNE 4, 2021
Approval of the Month: Non-Opioid for Post-Surgical Pain Gets FDA Nod. Heron Therapeutic received FDA approval for its bupivacaine/meloxicam extended-release solution product to treat post-operative pain after total knee replacement, bunionectomy, and groin hernia repair. Since two-thirds of the more than 50 million U.S.
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