Ethical Considerations for Clinical Investigations of Medical Products Involving Children
Clinical / Medical (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 23, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Issues New Guidance to Help Facilitate Availability of Naloxone to Prevent Opioid Overdoses and Reduce Death
The FDA is building on our actions by helping facilitate the availability and access to this life saving medication. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 23, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Guidance Recap Podcast | Ethical Considerations for Clinical Investigations of Medical Products Involving Children
Thoughts on newly published draft guidance titled, “Ethical Considerations for Clinical Investigations of Medical Products Involving Children.” (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 23, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Guidance Recap Podcast | Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments
Guidance Recap Podcast: Selecting, Developing or Modifying Fit-for-Purpose Clinical Outcomes Assessments (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 22, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Data Standards Catalog v8.2
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 22, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency Guidance for Industry
Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 22, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive non-small cell lung cancer
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 21, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 21, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Excipients and Formulation Assessments of Complex Generic Products: Best Practices and Lessons Learned Webinar - 12/06/2022
The goal of this webinar is to provide an overview of the regulatory framework, scientific concepts, product-specific challenges, and best practices related to development of complex generic drug products that are either required or recommended to have the same formulation as their respective RLDs. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 21, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA/IMS Joint Workshop: Future of Drug Development in Multiple Myeloma - 11/08/2022
On November 8-9, 2022, the U.S. Food and Drug Administration (FDA) and the International Myeloma Society (IMS) will host a joint symposium, to provide a forum for open discussion among academia, industry, and regulatory agencies about clinical drug development in multiple myeloma. The event will be held in person and online. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 21, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

How To Obtain a Covered Product Authorization
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 21, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA approves sodium thiosulfate to reduce the risk of ototoxicity associated with cisplatin in pediatric patients with localized, non-metastatic solid tumors
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 20, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD
Generics /User Fees (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 20, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Drug Supply Chain Security Act Product Tracing Requirements Frequently Asked Questions
Drug Supply Chain Security Act Product Tracing Requirements Frequently Asked Questions (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 20, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Salon Technologies, Inc. Issues Voluntary Nationwide Recall of Antica Ocean Citron Hand Sanitizer ( Alcohol ) Gel 65% Due to the Presence of Benzene
Orlando, Florida. Salon Technologies International. Inc. is voluntarily recalling one lot of Antica Ocean Citron Hand Sanitizer (alcohol) Gel 65%, Lot 1166A. Expiration 6/18/2023 to the consumer level. Firm lab testing has found the product to contain benzene. Benzene is classified as a human carci (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 20, 2022 Category: Drugs & Pharmacology Authors: FDA Source Type: news