Pharmaceutical Technology

DECEMBER 15, 2022

Inflation at its current levels poses a major threat to generics production and usage. Since the summer, generics makers have been signalling that additional support for help with rising costs is required to keep generics production viable.

Medicine 246

Medicine Manufacturing Pharma Companies Production 246

Camargo

NOVEMBER 11, 2020

When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely. Manager of Regulatory Compliance. Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning.

Development 242

Development Bioequivalency Generic Drugs Production 242

FDA Law Blog

SEPTEMBER 6, 2023

Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility.

Generic Drugs 45

Generic Drugs Manufacturing Drugs Cosmetics 45

Camargo

SEPTEMBER 8, 2021

The drugs approved via PANDAs are often used as the reference listed drug (RLD) for ANDAs under 505(j), and they can also be used as the listed drug for 505(b)(2) applications. PANDAs have historically been overseen by the FDA’s Office of Generic Drugs and thus regulated more like a generic than an NDA.

Development 186

Development Regulation Production Drugs 186

FDA Law Blog

MARCH 6, 2024

Claud will be featured at the Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products in New York, NY. Prior to HP&M, John served 15 years at the Department of Justice, serving most recently as the Assistant Director of the Consumer Protection Branch, where he led the Corporate Compliance and Policy Unit.

Cosmetics 59

Cosmetics Compliance Generic Drugs Regulation 59

Pharma Marketing Network

FEBRUARY 27, 2025

Introduction Pharma marketing is changing, and pay-per-click advertising (PPC) is leading the charge. But how can pharma marketers maximize their PPC campaigns while staying compliant with strict regulations? Why PPC is Essential for Pharma Marketing The pharma industry operates in a highly regulated and competitive space.

Branding 52

Branding Marketing Compliance Engineer 52

pharmaphorum

JUNE 3, 2021

The FDA approval of Alkermes’ new antipsychotic drug Lybalvi couldn’t have gone any better for the company, but it could still face a big challenge positioning the new drug in the highly genericised market. It has however been contraindicated in people taking opioids.

FDA Approval 52

FDA Approval Marketing Branding Generic Drugs 52

XTalks

AUGUST 30, 2022

Strategic leaders know how to think critically and navigate through daily challenges that are bound to emerge in this competitive market. The pharmaceutical industry deals with threats such as product liability, cyberthreats, supply chain disruptions, competition from generic drugs and more. Transformational Leadership.

Life Science 105

Life Science Generic Drugs Drug Delivery Compliance 105

Pharmacy Checkers

DECEMBER 12, 2019

The GAO’s preliminary analysis on inspections brings back into light what Katherine Eban so passionately – and dramatically – exposed in her book Bottle of Lies: The Inside Story of the Generic Drug Boom.” A majority of inspections resulted in findings of non-compliance. based inspectors who go overseas, 66 remained unfilled.

Drugs 71

Drugs Manufacturing Medicine Regulation 71

Cloudbyz

MARCH 5, 2024

Administration and Dosage: Due to their nature, biologics are often administered via injection or infusion, which can affect patient compliance and convenience. Such support can reduce the time and cost associated with bringing a new biologic to market. Ensuring batch-to-batch consistency is a significant challenge.

Development 97

Development Drugs Immune Response Manufacturing 97

pharmaphorum

JULY 28, 2022

Logistical challenges of getting the right materials in the right place remain two years after the pandemic began, causing significant drug shortages to end-users. Many of the medicines most badly affected by these shortages are generic drugs to treat common conditions such as diabetes and heart disease. The stakes are high.

Compliance 111

Compliance Drugs Manufacturing Generic Drugs 111

Camargo

MAY 10, 2021

The public’s faith in drugs approved under the FDA’s accelerated approval program is not blind — it relies heavily on the industry’s follow-through on confirmatory trials and the FDA’s subsequent review and final approval. So, we are perhaps a step closer to remote inspections, but not there yet. How Can I Get my ANDA Program Back on Track?

Development 185

Development Clinical Trials Clinical Trials Trials 185

Pharma in Brief

JANUARY 9, 2022

These policy initiatives included reforms to the Patented Medicine Prices Review Board ( PMPRB ), the Patented Medicines (Notice of Compliance Regulations) ( PM(NOC) Regulations ), the Patent Rules , and other regulatory matters at Health Canada. The courts also had a busy year in 2021.

Regulation 52

Regulation Manufacturing Drugs Medicine 52

FDA Law Blog

AUGUST 21, 2023

FDA approves (or sometimes dictates depending on the product and regulatory pathway to market) the content of drug product labeling to set forth the conditions of use for which the benefits of the product outweigh the risks. More than a few have taken far longer—literally decades.

FDA Approval 40

FDA Approval Production Drugs Generic Drugs 40

Drug Patent Watch

MARCH 25, 2025

Breaking into the Generic Drug Market: Strategies for Success As a pharmaceutical professional, you know that the generic drug market is a highly competitive space. With new generic drugs entering the market every year, it can be challenging to stand out from the crowd and achieve success.

Generic Drugs 52

Generic Drugs Marketing Drugs Compliance 52

Drug Patent Watch

FEBRUARY 12, 2025

Accelerating Generic Drug Development: Strategies for Success As a pharmaceutical professional, you know how crucial it is to navigate the complex landscape of generic drug development. The generic drug development process involves several stages, from patent research to regulatory approvals.

Generic Drugs 81

Generic Drugs Development Drugs Manufacturing 81

Drug Patent Watch

APRIL 9, 2025

"Market Domination Through Cost Optimization: A Game-Changer for Generic Drug Manufacturers As the pharmaceutical industry continues to evolve, generic drug manufacturers are facing increasing pressure to reduce production costs while maintaining quality and regulatory compliance.

Generic Drugs 40

Generic Drugs Production Marketing Drugs 40

Pharma Marketing Network

MARCH 12, 2025

Without precise targeting, ad spend can be wasted on irrelevant searches, reducing conversion rates and compliance effectiveness. Pharmaceutical marketers face a unique challenge. But how do you balance compliance with visibility? Generic drug manufacturers, healthcare providers, and wellness brands often bid on similar terms.

Marketing 59

Marketing Research Compliance Branding 59

Pharma Marketing Network

NOVEMBER 24, 2024

But how do you stand out in a crowded market? Let’s explore the top strategies pharma marketers can adopt to thrive. Understanding the Pharma Market Landscape To succeed, you need to understand the shifting dynamics of healthcare marketing. Pro Tip: Ensure content aligns with search trends and branded drug names.

Sales 52

Sales Marketing Compliance Branding 52

Pharma Marketing Network

FEBRUARY 27, 2025

Introduction In todays fast-paced world, pharma digital marketing is more than just a strategyit’s a necessity. But how can pharma marketers break through the noise, engage their audience, and see real ROI? Think of digital marketing as the GPS guiding your brand through a crowded, competitive landscape.

Branding 52

Branding Marketing Compliance Regulation 52