Posts tagged with: "fda"
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3 Apr 2024, 10:00 pm
The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) studies. [read post]
3 Apr 2024, 10:00 pm
The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) studies. [read post]
3 Apr 2024, 10:00 pm
The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) studies. [read post]
3 Apr 2024, 10:00 pm
The US Food and Drug Administration (FDA) released a draft guidance on April 3 providing recommendations to sponsors and testing sites on data integrity for bioavailability and bioequivalence (BA/BE) studies. [read post]
3 Apr 2024, 9:00 pm
FDA’s future depends on it. [read post]
3 Apr 2024, 8:18 pm
The case arose over a brief (one week) importation of two transcatheter heart valve systems (Class III medical devices, subject to regulatory approval by FDA) by Meril in conjunction with attendance by their representatives at a medical conference. [read post]
3 Apr 2024, 3:36 pm
., based on FDA review of a regulated product) will increase 468% from US$1,180 to US$6,700 New Fees Aimed at Cost Recovery After Final Consideration Pilot Program Request: US$500 Petitions associated with unintentional delay of > 2 years: US$3,000 New Fees That Could Change Applicant Behavior Continuing Application Surcharge, filed ≥ 5 years after earliest benefit date: US$2,200 Continuing Application Surcharge, filed ≥ 8 years after earliest benefit date: US$3,500 The… [read post]
3 Apr 2024, 1:07 pm
In the case, Teva asserts that Amneal’s Abbreviated New Drug Application (“ANDA”) for an asthma inhaler infringes upon five patents it has listed in the FDA’s Orange Book–a challenge that under FDA regulations triggers a 30-month stay of FDA’s approval of the generic inhaler. [read post]
3 Apr 2024, 12:00 am
It has been approved by the Food and Drug Administration (FDA) for pain relief and anesthesia. [read post]
2 Apr 2024, 9:02 pm
Use link above to go to FDA page with links to specific alerts. [read post]
2 Apr 2024, 7:10 pm
Finally, in response to the GSK and Teva litigation, FDA continues to ask for a legislative fix. [read post]
2 Apr 2024, 3:11 pm
The products are being recalled as a precaution in full cooperation with the FDA. [read post]
2 Apr 2024, 12:56 pm
Lay juries usually function well in assessing the relevance of an expert witness’s credentials, experience, command of the facts, likeability, physical demeanor, confidence, and ability to communicate. [read post]
2 Apr 2024, 11:09 am
" Again, the lawyer agreed, at which point Alito said this: "Do you think the FDA is infallible? [read post]
2 Apr 2024, 9:50 am
FDA, 379 F.Supp.3d 461 (D. [read post]
2 Apr 2024, 9:13 am
Reed Smith will continue to follow developments on this and other issues facing compounding pharmacies and FDA regulation. [read post]
2 Apr 2024, 9:00 am
Subpart B.[1] A few years later, in July 2019, FDA finalized a guidance ... [read post]
2 Apr 2024, 3:01 am
The FDA has warned that Keppra, Keppra XR, Spritam, Elepsia XR, Sympazan, and Onfi can trigger DRESS. [read post]
1 Apr 2024, 10:36 pm
In the months leading up to the FDA shutting down plaintiff’s business, one of the co-owners of the business left and set up a competing enterprise. [read post]
1 Apr 2024, 9:05 pm
The FDA is reminding consumers of the risks associated with raw milk consumption in light of the HPAI detections. [read post]
