The FDA Law Blog

SEPTEMBER 16, 2024

Schwartz — FDA recently published a Federal Register (FR) Notice [ Docket No. FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies.

Documentation 59

Documentation FDA Communication 59

The FDA Law Blog

FEBRUARY 2, 2025

California pharmacists are still able to provide the oral therapeutics without requiring you to visit your primary care physician through January 1, 2026. The most common drug Californians may be looking for this winter is Paxlovid. The California Board of Pharmacy updated many of the application forms and guidelines in late 2024.

Packaging 59

Packaging Documentation Compounding 59

The FDA Law Blog

FEBRUARY 21, 2024

Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. FDA further retained some definitions in the QSMR. The new § 820.10 Revised § 820.3

FDA 59

FDA Labelling Packaging Documentation 59

pharmaphorum

SEPTEMBER 23, 2022

Chances of FDA approval for Spectrum Pharma’s lung cancer candidate poziotinib and Oncopeptides’ Pepaxto for multiple myeloma have taken a dive, after the regulator’s expert advisors voted that the drugs were not ready to reach the market. Shares in the company were down 27% in after-hours trading.

FDA 52

FDA Documentation 52

The FDA Law Blog

JULY 7, 2024

Unfortunately, the guidance for small entities recently published by FDA is little more than a summary digest of the multi-hundred-page final rule. However, the guidance provides no new information on how FDA expects laboratories to implement these new requirements.

Labelling 64

Labelling FDA Communication Documentation 64

DiversifyRx

JULY 11, 2024

Small Dispensers and the 6/12/2024 FDA Announcement Concerning DSCSA This week’s article on the recent DSCSA postponement comes from PRS Pharmacy Services. The exemption will last until November 27, 2026, for those small dispensers who qualify. We need more clarity here to see what the FDA is planning.

Independent Pharmacies 52

Independent Pharmacies FDA Documentation CPhT 52

The FDA Law Blog

NOVEMBER 11, 2024

Livornese & JP Ellison — On November 8, 2024, FDA issued a proposed order to remove the oral decongestant ingredient phenylephrine (including both phenylephrine hydrochloride and phenylephrine bitartrate) (collectively, PE) from the OTC monograph on the basis of a lack of effectiveness. By Deborah L.

FDA 111

FDA Documentation Dosage 111