News & Analysis as of

Pharmaceutical Industry › Sponsors › Prescription Drugs

Goodwin

Move Fast: FDA is Accepting Submissions for the Pilot Program Class for FDA Commissioner’s National Priority Voucher Program

Goodwin on

FDA is now accepting submissions to the Commissioner’s National Priority Voucher (CNPV) pilot program, and with only five vouchers to be awarded as part of the initial year of the program, the competition is anticipated to be...more

BakerHostetler

FDA Authorizes Florida’s Drug Importation Program

BakerHostetler on

On Jan. 5, the FDA authorized Florida’s Section 804 Implementation program (SIP), making Florida the first state to secure such approval. Generally, there are three pathways to importing a prescription drug into the United...more

Goodwin

FDA Issues Draft Guidance on Formal Meetings between the FDA and Sponsors or Applicants of BsUFA Products and Classification...

Goodwin on

In August 2023, the Food and Drug Administration issued two draft guidance, both related to the development of biosimilar products, entitled “Formal Meetings between the FDA and Sponsors or Applicants of BsUFA Products” and...more

Goodwin

FDA’s Final Q&A Guidance on Risk-Based Monitoring of Clinical Trials Provides Additional Recommendations for Sponsors

Goodwin on

The U.S. Food and Drug Administration (FDA) recently finalized its guidance, “A Risk-Based Approach to Monitoring of Clinical Investigations” (the “2023 RBM Guidance”) which follows up on the Agency’s March 2019 draft...more

Goodwin

Leveraging Investigator-Initiated Trials in Rare Disease Drug Development

Goodwin on

Investigators interested in rare disease treatment development have the opportunity to approach drug and biologic developers to obtain investigational drug supply for trials in which the investigators, typically at academic...more

5 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide