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Transfer responsibility from Discovery to - accessdata fda

Transfer responsibility from Discovery to - accessdata fda 2025

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The document outlines the regulatory review process for the drug Surfaxin (lucinactant), intended for the prevention of respiratory distress syndrome in premature infants. It details the transfer of quality assurance responsibilities, the need for post-marketing requirements (PMRs) and commitments (PMCs), and various inspections conducted to ensure compliance with good laboratory practices (GLP). The document also discusses issues related to data integrity, labeling vulnerabilities, and recommendations for further training and procedural improvements within Discovery Laboratories. Overall, it emphasizes the importance of rigorous oversight in clinical trials and manufacturing processes to ensure drug safety and efficacy.

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What is 312.52 transfer of obligations to a contract research organization?

312.52 Transfer of obligations to a contract research organization. (a) A sponsor may transfer responsibility for any or all of the obligations set forth in this part to a contract research organization. Any such transfer shall be described in writing. 21 CFR 312.52 -- Transfer of obligations to a contract - eCFR ecfr.gov part-312 subpart-D section-312 ecfr.gov part-312 subpart-D section-312

What is the transfer of rights and obligations to a third party?

An assignment is the transfer of rights under a contract from one party (the assignor) to another party (the assignee). When a party assigns their rights under a contract, they are essentially transferring their ability to receive benefits or enforce terms of the contract to someone else.

What is an example of a novation obligation?

For example, a person as a seller agrees with the buyer to pay the price to a third party, as new creditor of its debt. In this case, the debtor will be freed by the initial creditor, being bound to the new one, as effect of novation.

How do I transfer my IND to the FDA?

In order to transfer the IND, both the new and former owners are required to submit information to the FDA. This includes a letter from the former owner stating that all rights to the application have been transferred to the new owner and that the new owner will receive or has received the complete IND record. IDE or IND Transfers | Emory University | Atlanta GA emory.edu oric fda transfers emory.edu oric fda transfers

What is a 314.72 change in ownership of an application?

314.72 Change in ownership of an application. (1) The former owner shall submit a letter or other document that states that all rights to the application have been transferred to the new owner. 21 CFR 314.72 -- Change in ownership of an application. - eCFR ecfr.gov part-314 subpart-B section-314 ecfr.gov part-314 subpart-B section-314

What is a transfer of obligations?

The transfer of an obligation means that it leaves the original obligors assets to enter those of the new obligor. However, in some cases although the new obligor becomes bound towards the obligee, the original obligor is not discharged (see Article 9.2. CHAPTER 9 - Section 2 - UNIDROIT unidroit.org unidroit-principles-2010 ch unidroit.org unidroit-principles-2010 ch

What is a transfer of rights and obligations under a contract?

A transfer of rights contract allows you to transfer your contractual rights and responsibilities to another party. Transferring contract rights can happen either through assignment or delegation.

What is the transfer of obligations in a contract?

The transfer of rights or obligations must be voluntary and intentional. There must be a valid contract in place between the original parties. The assignment must be in writing and signed by the parties involved. The assignment of contract rights and obligations is subject to various legal requirements.

Transfer responsibility from Discovery to - accessdata fda 2025

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