Advarra

JULY 19, 2022

Q: What is the typical time period between the submission of the briefing package and the pre-IND meeting? A: The FDA’s guidance document indicates the briefing package is submitted four weeks before the meeting. Q: The speaker just stated that the Meeting Package is due 60 days before the meeting date. of this guidance.

Packaging 52

Packaging FDA Trials Regulations 52

Agency IQ

JANUARY 12, 2024

These windows depend on whether the new drug application (NDA) or biologics license application (BLA) is a new molecular entity, and if the application has received standard review (10 months, plus 2 months of administrative time) or priority review (6 months, plus 2 months of administrative time).

FDA 40

FDA Drugs Production Licensing 40

Agency IQ

JANUARY 26, 2024

Under the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) , the FDA also has some authority to extend MCM expiration dates. What happens when a drug is not stored in its original container or within a licensed facility? Enter the beyond-use date.

Science 40

Science FDA Production Packaging 40

Agency IQ

JUNE 2, 2023

Within the realm of FDA-required labeling, there are currently a few different types of information a sponsor might develop specifically for patient use: medication guides, instructions for use (IFU), consumer medical information (CMI) and patient package inserts (PPI).

FDA 40

FDA FDA Approval Production Regulations 40

Agency IQ

JUNE 16, 2023

2) Update delivery timing and methods to require community water systems that serve 10,000 or more persons to provide reports biannually; and allow electronic delivery methods consistent with the “Safe Drinking Water Act–Consumer Confidence Report Rule Delivery Options” issued by the EPA on January 3, 2013.

Regulations 40

Regulations Compliance Production Science 40

Agency IQ

JULY 28, 2023

DSCSA implementation – Down to the wire as a deadline draws near: The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 as part of the Drug Quality and Security Act (DQSA), following several drug counterfeiting scandals in which falsified medical products entered the supply chain.

FDA 40

FDA Science Biosimilars Regulations 40

Drug & Device Law

DECEMBER 29, 2023

Equally bad, Hrymoc effectively read a New Jersey statute, §2A:58C-5(c), which precludes punitive damages where a “device” was “licensed” by the FDA, out of existence. The G/N MDL was created in 2013 and mostly settled in 2016. That makes Hrymoc a one-off exception from a general exclusion of §510(k) evidence. 3d , 2023 WL 5807340 (D.

Testimonials 105

Testimonials FDA Drugs Vaccine 105