The FDA Law Blog

JANUARY 7, 2024

A review of FDA’s Postmarketing Requirements and Commitments database reveals that one of the most common reasons FDA requires postmarketing studies is to assess the impact of a drug on maternal and fetal outcomes when taken by pregnant women. For post-approval pregnancy studies, it most certainly does.

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ISPE

MAY 9, 2023

Jaguar Gene Therapy is building a $125 million facility in RTP to manufacture adeno-associated virus (AAV)-based gene therapies, Beam Therapeutics is constructing an $83 million plant to develop precision medicines, and IQVIA, a CRO, opened an innovation lab in the park in 2021, focusing on bioanalytics, vaccines, biomarkers, and genomics.

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The FDA Law Blog

APRIL 7, 2025

Koblitz & Dara Katcher Levy Promotional claims do not receive the most attention with respect to FDA enforcement these days, and veterinary promotion is no exception. Zenrelia comes with serious warnings, including a boxed warning against the use of Zenrelia during vaccination.

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pharmaphorum

SEPTEMBER 18, 2020

In 1990, the US Food and Drug Administration (FDA) requested Astra to change Losec’s brand name to Prilosec, to avoid confusion with Sanofi-Aventis’ diuretic, Lasix (furosemide). In June 2007, AstraZeneca completed the acquisition of vaccine maker MedImmune, buying its drug-development pipeline for $15.2 Pfizer makes its move.

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ISPE

OCTOBER 26, 2022

ATMP facilities are different from conventional pharmaceutical facilities that process other traditional modalities, such as vaccines and monoclonal antibodies (mAbs), and often require heightened segregation and smaller footprints. FDA CFR Title 21 Parts 211, 600, and 1271; 8. , Complete Data Gathering.

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pharmaphorum

NOVEMBER 16, 2020

In his final message as head of the EMA, Rasi said the number of COVID-19 drugs and vaccines being developed by pharma companies is “encouraging,” and pointing to the agency’s pivotal role “in reviewing the available data packages to ensure that our usual high standards of safety, efficacy and quality are achieved and upheld.”.

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ISPE

SEPTEMBER 11, 2023

Sanofi Pumps $554M into New Vaccine Manufacturing Facility in Eastern France.” www.fiercepharma.com/manufacturing/sanofi-pumps-554m-into-new-vaccine-manufacturing-facility-eastern-france 41 Boccard. New Project: Evolutive Vaccines Facility for Sanofi.” www.boccard.com/evolutive-vaccines-facility-for-sanofi/ 42 Amgen.

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PharmaShots

APRIL 13, 2023

Its subsidiary, DePuy's CHARITE Artificial Disc for degenerative disc disease was the first device to be approved by the US FDA By acquiring Roche’s OTC business, Bayer was able to strengthen its consumer health business. Its top 8 products contributed more than $1B to the company’s net revenue. to the revenue.

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PharmaShots

JANUARY 31, 2023

MyoVista wavECG is the company’s first FDA-cleared product which is designed to provide diagnostic information related to cardiac dysfunction in addition to being a resting 12-lead ECG. LP-310, another lead asset of the company received FDA Type-B Pre-IND guidance recently for Oral Lichen Planus. Founded Year: 2014 No.

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Pharmaceutical Technology

NOVEMBER 22, 2022

Vaccines are our number one weapon in the fight against infectious diseases, but their development has historically involved a long and complex process taking up to a decade. Before COVID-19, Merck held the record for the fastest modern vaccine ever developed. mRNA’s potential for rapid vaccine delivery.

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ISPE

MARCH 8, 2023

Identification and Analysis of Contamination Trends Three major recall databases—those of the US FDA, the United Kingdom’s Medicine and Healthcare Products Regulatory Agency (UK MHRA), and Australia’s Therapeutic Goods Administration (TGA)—were searched to assess contamination trends in the past five years.

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pharmaphorum

SEPTEMBER 21, 2020

AstraZeneca may have had a rough ride following a safety scare with its COVID-19 vaccine, but the company’s busy pipeline is producing successes in other areas. Lynparza was the first PARP (poly (ADP-ribose) polymerase) drug on the market in 2014, first approved in the US for ovarian cancer. months versus 17.7

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PharmaShots

MARCH 22, 2023

As per the terms of the agreement, Immunomedics received an up front payment of $65M and would have been eligible to receive $60M in regulatory milestones upon the approval of sacituzumab govitecan by the US FDA to treat mTNBC. As per the transaction, Bavarian received an up front payment of $10M and $33M in up front equity investment.

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The Checkup by Singlecare

JULY 31, 2024

Gardasil 9 isn’t just for girls and women; boys and men can benefit from this vaccine too. In 2014, the Food and Drug Administration (FDA) approved Gardasil 9 for females between the ages of 9 and 26 and males between the ages of 9 and 15. Given these updates, many people are now eligible for the vaccine.

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The FDA Law Blog

FEBRUARY 4, 2025

With the current lapse in authorization, FDA may only award RPD PRVs for applications that have received an RPD designation before December 20, 2024, andunless reauthorized before thenmay not award any RPD PRVs after September 30, 2026. Below, we discuss some of its downstream impacts on the PRV landscape.

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