FDA Law Blog: Biosimilars

SEPTEMBER 12, 2023

In this webinar you’ll learn: How employees diverted controlled substances — their methods are constantly evolving What red flags were missed DEA inspection priorities Safeguards to minimize internal diversion Best practices for maximizing diversion detection Mr. Houck was a DEA Diversion Investigator for 15 years prior to joining HPM in 2001.

Controlled Substances 49

Controlled Substances Hospitals 49

PharmaShots

APRIL 7, 2023

TG Therapeutics Receives EMA’s CHMP Positive Opinion of Briumvi (ublituximab-xiiy) for the Treatment of Relapsing Forms of Multiple Sclerosis Date: Apr 3, 2023 | Tags: TG Therapeutics, Briumvi, Ublituximab-xiiy, Multiple Sclerosis, Regulatory, EMA, CHMP BMS Receives EMA’s CHMP Positive Opinion of Breyanzi (lisocabtagene maraleucel) for (..)

Biosimilars 53

Biosimilars Immunization Immunity 53

FDA Law Blog: Biosimilars

SEPTEMBER 26, 2023

In this webinar you’ll learn: How employees diverted controlled substances — their methods are constantly evolving What red flags were missed DEA inspection priorities Safeguards to minimize internal diversion Best practices for maximizing diversion detection Mr. Houck was a DEA Diversion Investigator for 15 years prior to joining HPM in 2001.

Controlled Substances 45

Controlled Substances Hospitals 45

pharmaphorum

FEBRUARY 18, 2021

In late 2017, the FDA approved Admelog, Sanofi’s biosimilar of Humalog. AstraZeneca’s patent for its top-selling gastroesophageal reflux disease drug was due to expire in 2001. Simultaneous with the switch to NEXIUM, AstraZeneca grew its overall Gastroenterology franchise – by nearly 9% from 2001 to 2002. billion in 2004.14

Prescription Filling 52

Prescription Filling Drug Pricing Biosimilars Compounding 52

FDA Law Blog: Biosimilars

MAY 22, 2023

Before joining HP&M in 2001, Mr. Houck conducted numerous scheduled cyclic and targeted inspections and investigations as a DEA Diversion Investigator in the field for ten years. Registrants are far from powerless when DEA investigators inspect their controlled substance operations.

Controlled Substances 40

Controlled Substances 40

FDA Law Blog: Biosimilars

OCTOBER 4, 2023

Engler , a 2001 decision by the Sixth Circuit Court of Appeals. While this standard is different from the standard applicable to the underlying cases, some of the analysis coincides with those cases. The Plaintiffs argued the unconstitutionality of the Medicare Negotiation Program under the Fifth Amendment by relying on Michigan Bell v.

Drug Pricing 59

Drug Pricing Pharmaceutical Manufacturing Immunization Immunity 59

FDA Law Blog: Biosimilars

MAY 23, 2023

Since then, the science and legal and regulatory framework for food allergens have evolved considerably: Congress enacted the Food Allergen Labeling and Consumer Protection Act (2004) and the Food Safety Modernization Act (2011), and FDA implemented the regulatory requirements set forth in 21 C.F.R.

Labelling 45

Labelling 45

FDA Law Blog: Biosimilars

APRIL 23, 2023

Outstanding Questions This Draft Guidance expands on the 2001 ICH E10 guidance (Choice of Control Group and Related Issues in Clinical Trials) and does a fairly thorough job describing the limitations and challenges facing sponsors seeking to use an externally controlled trial, particularly using RWD.

Documentation 49

Documentation Drug Development 49

FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

Not surprisingly, then-presidential candidate Asa Hutchinson, DEA Administrator from 2001 to 2003, did not sign the letter. The letter is signed by six former DEA administrators and five former Directors of National Drug Policy. The earliest tenured is John Bartels, who served as Administrator from 1973 to 1975.

Controlled Substances 59

Controlled Substances Chemotherapy Compounding 59