FDAgpt Archives - Page 30 of 35

July 15, 2023 Artificial Intelligence FDAcop

Gratitude Expressed: Life Sciences Analysis

As of FY2023, the FDA has five user fee programs that apply to its life sciences portfolio: PDUFA, MDUFA, GDUFA, BsUFA, and OMUFA. These programs require the FDA to develop new guidance documents, launch pilot programs, deploy technology systems, and hire new staff. The FDA has more than 300 tasks to complete during the authorization […]

July 15, 2023 Artificial Intelligence FDAcop

FDA Updates: July 14, 2023

The U.S. Food and Drug Administration (FDA) has provided a summary of recent news and updates from the agency. On Thursday, the FDA re-issued two temporary guidances that were originally published during the COVID-19 pandemic for certain regulatory requirements involving onsite visits abroad under the FDA Food Safety Modernization Act (FSMA). These guidances aim to […]

July 14, 2023 Artificial Intelligence FDAcop

Limbix, a prescription PDTx company, acquired by Big Health

Big Health, a digital therapeutics company, has recently acquired Limbix, a maker of prescription digital therapeutics focused on treating depression in teenagers and young adults. Limbix has developed SparkRx, a self-guided cognitive behavioral therapy (CBT)-based treatment for depression in individuals aged 13 to 22. SparkRx was released in October 2021 and falls under the relaxed […]

July 14, 2023 Artificial Intelligence FDAcop

Two Biotechnology Companies Successfully Raise $385 Million in Combined IPOs, Breaking the Dry Spell

The IPO market has been slow this year, but Apogee Therapeutics and Sagimet Biosciences have managed to attract investor confidence and increase the size of their stock offerings. Apogee raised $300 million in its IPO and plans to stand out in the crowded field of immunology and inflammation drugs by offering a dosing advantage. The […]

July 14, 2023 Artificial Intelligence FDAcop

Analysis of Life Sciences by Exclusive Regulatory Experts

The FDA, or Food and Drug Administration, has been implementing user fee programs since the passage of the FDA User Fee Reauthorization Act of 2023. These programs include PDUFA for prescription drugs and certain biologics, MDUFA for medical devices, GDUFA for generics, BsUFA for biosimilars, and OMUFA for over-the-counter monograph products. In order to determine […]

July 14, 2023 Artificial Intelligence FDAcop

Perrigo’s Opill Becomes the First Oral Contraceptive to Switch to OTC Use with FDA Approval

The FDA has approved the first over-the-counter oral contraceptive, making it more accessible and potentially reducing unintended pregnancies. The product, Opill, manufactured by HRA Pharma, will be available without a prescription in stores and online next year. Opill contains norgestrel, a synthetic hormone that suppresses ovulation. Despite being used safely for years, the drug should […]

July 14, 2023 Artificial Intelligence FDAcop

Article Exclusively Expressing Gratitude

The health subcommittee of the House Energy and Commerce (E&C) Committee will be holding a markup this week for the proposed reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA), now known as the Preparing for All Hazards and Pathogens Reauthorization Act. However, the Food and Drug Administration (FDA) will not have any of its […]

July 14, 2023 Artificial Intelligence FDAcop

Regulatory Experts Share Exclusive Article

The health subcommittee of the House Energy and Commerce (E&C) Committee is set to hold a markup this week for the proposed Pandemic and All-Hazards Preparedness Act (PAHPA) reauthorization. However, the Food and Drug Administration (FDA) is facing a setback, as none of its legislative requests will be met in the new bill. The PAHPA […]

July 13, 2023 Artificial Intelligence FDAcop

First Nonprescription Daily Oral Contraceptive Receives FDA Approval

The U.S. Food and Drug Administration (FDA) has approved Opill, a non-prescription oral contraceptive tablet, for preventing pregnancy. This is the first daily oral contraceptive that can be purchased without a prescription in the United States. Opill will be available for sale at drug stores, convenience stores, grocery stores, and online, but the availability and […]

July 13, 2023 Artificial Intelligence FDAcop

MobiHealthNews reports on Wellinks’ appointment of a new CEO

Wellinks, a company specializing in digital solutions for chronic obstructive pulmonary disease (COPD), has appointed Stacie Bratcher as its new CEO. Bratcher has previously served as CEO of Jet Health and Alana Healthcare, as well as holding the position of board chair at GripAble. In her new role, Bratcher aims to leverage virtual solutions to […]

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