Pharmaceutical Technology

DECEMBER 15, 2022

Since the summer, generics makers have been signalling that additional support for help with rising costs is required to keep generics production viable. In June, generic drug manufacturing giants wrote to the EU to request help with rising costs so that their products remain viable.

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Drug Patent Watch

DECEMBER 10, 2024

Generic drug development is a complex process that requires a deep understanding of regulatory requirements and guidelines. Regulatory expertise plays a crucial role in ensuring that generic drugs meet the necessary standards for quality, safety, and efficacy. EU, and other regions.

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FDA Law Blog

AUGUST 16, 2023

Farquhar — Francis Godwin, Director of the Office of Manufacturing Quality of the Office of Compliance at FDA’s Center for Drug Evaluation and Research provided useful information (presentation attached here ) Tuesday at the GMP by the Sea Conference.

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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.

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Generic Drugs Manufacturing Drugs Cosmetics 45

Pharma in Brief

APRIL 25, 2021

salt forms) to be listed on the patent register and are intended to balance Proposed FDR Amendments [2] published on March 30, 2019 which allow generic manufacturers to file an ANDS for an alternative form of a medicinal ingredient in comparison to the CRP. Proposed FDR Amendments Create Imbalance in Linkage Regime.

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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.

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Development Regulation Production Drugs 186

FDA Law Blog

APRIL 8, 2024

This year’s report noted that CDER’s Drug Product Catalog contains over 140,000 entries, the same amount as OPQ listed in 2022. Readers also saw that that the Center’s manufacturing Site Catalog remains steady at more than 4,800 entries, the same number we found in the 2022 State of Pharmaceutical Quality report.

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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.

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Cosmetics Compliance Generic Drugs Regulation 59

Cloudbyz

MARCH 5, 2024

Manufacturing Process : Small Molecules: Manufactured through chemical synthesis, small molecule drugs can be consistently reproduced with a high degree of purity and stability. The conditions affecting the living system can influence the final product, making the manufacturing process more sensitive and challenging.

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FDA Law Blog

NOVEMBER 20, 2023

Of note, the new structure removes any separation between new and generic drug quality review offices. For example, in August, CDER and OPQ initiated the Quality Management Maturity Program (QMM) that aspires to “implement quality management practices that go beyond current good manufacturing practice (CGMP) requirements.”

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Pharmacy Checkers

DECEMBER 12, 2019

The FDA’s continuing problems with inspections of drug manufacturing plants, as well as the relative comparative strength of other drug regulators, ought to inspire serious reflection, even introspection, among drug safety policy professionals about whether or not, and how, we have the gold standard.

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pharmaphorum

JUNE 3, 2021

The US regulator approved Lybalvi (olanzapine/samidorphan) for both indications sought – schizophrenia and bipolar I disorder – with data on its label that includes a claim of less weight gain with olanzapine on its own, a big problem with the widely-used generic drug that affects compliance with treatment.

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XTalks

AUGUST 30, 2022

The pharmaceutical industry deals with threats such as product liability, cyberthreats, supply chain disruptions, competition from generic drugs and more. Public health and regulatory compliance entities depend on bureaucratic leadership to run effectively. Therefore, strategic intent is vital when making decisions.

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Life Science Generic Drugs Drug Delivery Compliance 105

pharmaphorum

JULY 28, 2022

The pandemic effectively shut down supply chain paths overnight, and as a result, pharmaceutical manufacturers have faced delays and bottlenecks, which have caused drug shortages in healthcare systems. So, what can we do to insulate against the risk of shortages in these crucial generic drugs? The stakes are high.

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Compliance Drugs Manufacturing Generic Drugs 111

Camargo

MAY 10, 2021

Possibly in response, the Agency has issued the guidance Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency. The title of the guidance is worth noting—“Remote Interactive Evaluations ,” not “Inspections.” How Can I Get my ANDA Program Back on Track?

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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. 2021 in the Courts.

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Regulation Manufacturing Drugs Medicine 52

FDA Law Blog

AUGUST 21, 2023

Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. This is because the presumption that manufacturers can unilaterally make substantive changes to the labeling of an OTC Monograph drug product is false.

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Drug Patent Watch

FEBRUARY 20, 2025

The Unseen Heroes of the Pharmaceutical Industry: Achieving High-Quality Standards in Generic Drugs As we navigate the complex world of healthcare, it's easy to overlook the unsung heroes who work tirelessly behind the scenes to bring affordable, high-quality medications to the masses.

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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.

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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.

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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.

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Pharma Marketing Network

MARCH 12, 2025

Without precise targeting, ad spend can be wasted on irrelevant searches, reducing conversion rates and compliance effectiveness. But how do you balance compliance with visibility? Competition for High-Value Keywords Branded drug names and general medical terms attract intense competition. A mix of branded (e.g.,

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