Drug Patent Watch

DECEMBER 10, 2024

Generic drug development is a complex process that involves not only scientific and medical expertise but also adherence to strict legal and ethical standards. Scientific expertise plays a crucial role in ensuring that generic drugs are held to the same standards of quality, safety, and efficacy as their brand-name counterparts.

Generic Drugs 98

Generic Drugs Bioequivalency Development Drugs 98

Bio Pharma Dive

JUNE 20, 2024

RxPass, which fills prescriptions for generic drugs, is now available to more than 50 million Medicare members after Amazon brought it into compliance with the insurance program’s regulatory standards.

Generic Drugs 154

Generic Drugs Compliance Drugs 154

ACRP blog

FEBRUARY 11, 2025

The Health Care Compliance Association (HCCA), a nonprofit membership organization supporting healthcare compliance professionals, was founded, in part, to be your eyes and ears for compliance updates and regulatory changes. Group discounts are available; bring your team for shared learning!

Compliance 59

Compliance Clinical Research Research Regulation 59

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.

Generic Drugs 52

Generic Drugs Development Bioequivalency Drugs 52

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. Presumably, Antares’ long-established 90-person urology sales force can achieve pull-thru of this drug product.

Development 242

Development Bioequivalency Generic Drugs Production 242

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. Inflation can damage production viability of European drugs.

Medicine 246

Medicine Manufacturing Pharma Companies Production 246

Pharmaceutical Technology

JUNE 5, 2023

Earlier this year, Sun Pharmaceutical Industries , one of India’s largest generic drug producers, reported a major cybersecurity breach , impacting its business operations. Right now, it’s compliance by checkbox, in a static way.

Genome 276

Genome Genomics Regulation Compliance 276

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. After his remarks, Mr.

Generic Drugs 97

Generic Drugs Compliance Manufacturing Drugs 97

FDA Law Blog

JANUARY 22, 2024

Claud — The Office of Compliance (OC) at FDA’s Center for Drug Evaluation and Research (CDER) had a role in many of the major public health enforcement matters you may have read about last year. OC devoted a lot of resources to its compliance efforts directed at human drug compounding. Drug Supply Chain.

Compliance 59

Compliance Clinical Trials Clinical Trials Regulation 59

FDA Law Blog

SEPTEMBER 6, 2023

Farquhar — A drug manufacturer’s bad post-inspection grade from the U.S. 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. By Douglas B.

Generic Drugs 45

Generic Drugs Manufacturing Drugs Cosmetics 45

Camargo

SEPTEMBER 8, 2021

Some Drugs May Require Reclassification to Devices. On August 9, the FDA published a Federal Register notice requesting information and comments regarding products currently classified as drugs which may require reclassification as devices. This is in response to the decision from the U.S.

Development 186

Development Regulation Production Drugs 186

Pharma in Brief

APRIL 25, 2021

As previously reported , the Proposed FDR Amendments were intended to clarify the regulatory requirements under the Abbreviated New Drug Submission (“ ANDS ”) pathway for generic drug products that contain different forms (e.g., Interested persons have 30 days to make representations concerning the Proposed PM(NOC) Amendments.

Regulation 98

Regulation Medicine Generic Drugs Containment 98

FDA Law Blog

MAY 1, 2024

proudly announces the return of attorney Sarah Wicks to its drug development and compliance group. Sarah brings a wealth of experience and a proven track record of advising innovative drug and biologics companies through the intricate landscape of product development and commercialization. Hyman, Phelps & McNamara, P.C.

Development 52

Development Drugs Compliance Clinical Trials 52

Cloudbyz

MARCH 5, 2024

In the intricate dance of drug discovery and development, two protagonists emerge as the cornerstones of modern medicine: biologics and small molecules. Manufacturing Process : Small Molecules: Manufactured through chemical synthesis, small molecule drugs can be consistently reproduced with a high degree of purity and stability.

Development 97

Development Drugs Immune Response Manufacturing 97

Pharmacy Checkers

DECEMBER 12, 2019

wholesale importation of lower-cost drugs. Opponents of Americans buying less expensive drugs from overseas pharmacies (i.e. Food and Drug Administration exemplifies the “gold standard” in drug safety. is not the gold standard in drug safety, it would fatally weaken anti-importation arguments. If the U.S.

Drugs 71

Drugs Manufacturing Medicine Regulation 71

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

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. In a display of the competition within the generic industry that keeps margins low , this total included 118 new drug applications and 956 generic drug applications.

Manufacturing 59

Manufacturing Compliance Drugs Generic Drugs 59

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.

Life Science 105

Life Science Generic Drugs Drug Delivery Compliance 105

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. In its favour?

FDA Approval 52

FDA Approval Marketing Branding Generic Drugs 52

FDA Law Blog

NOVEMBER 20, 2023

Claud — The word last week was that FDA is re-organizing the Office of Pharmaceutical Quality (OPQ) within the Center for Drug Evaluation and Research (CDER). Those efforts add up to a clear message to industry that FDA is looking beyond CGMP when it evaluates drug makers. The new parts of OPQ reflect that.

Manufacturing 59

Manufacturing Generic Drugs Drugs Research 59

Pharma Marketing Network

FEBRUARY 27, 2025

The ability to target based on demographics, interests, location, and behavior makes PPC a game-changer for pharma brands promoting prescription drugs, disease awareness, and patient education resources. PPC provides the tools to navigate compliance while reaching the right audience effectively.

Branding 52

Branding Marketing Compliance Engineer 52

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. Many of the medicines most badly affected by these shortages are generic drugs to treat common conditions such as diabetes and heart disease.

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. Drug Product. FDA’s Accelerated Approval Program Comes Under Fire. Indication. Triple-negative breast cancer.

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. 2021 in the Courts.

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.

FDA Approval 40

FDA Approval Production Drugs Generic Drugs 40

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. Share your thoughts in the comments below!

Generic Drugs 96

Generic Drugs Drugs Manufacturing Compliance 96

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

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

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. But how do you balance compliance with visibility? Many terms, particularly those related to prescription drugs, require fair balance, risk disclosures, and approved messaging. A mix of branded (e.g.,

Marketing 59

Marketing Research Compliance Branding 59

Pharma Marketing Network

FEBRUARY 27, 2025

Unlike traditional marketing, digital marketing allows brands to engage with HCPs and patients in real time while maintaining compliance with industry regulations. Drive prescription intent by educating HCPs about the latest drug advancements. Ensure compliance while leveraging digital tools for outreach.

Branding 52

Branding Marketing Compliance Regulation 52

Pharma Marketing Network

NOVEMBER 24, 2024

The rise of generic drug competitors, stringent regulatory environments, and increasingly empowered patients mean one-size-fits-all approaches no longer work. Highlight evidence-based benefits of branded drugs like Januvia or Keytruda to establish credibility. Non-compliance can cost dearly. What resonates with them?

Sales 52

Sales Marketing Compliance Branding 52