FDA Law Blog

APRIL 8, 2024

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. OPQ also worked on 55 novel drug approvals for products with new molecules. The role of technology on quality was another feature.

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Manufacturing Compliance Generic Drugs Drugs 59

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.

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Regulation Medicine Generic Drugs Containment 98

Camargo

NOVEMBER 11, 2020

The ANDA application must contain a basis of submission specifying the RLD, and the applicant must show that the proposed generic drug is the same as the RLD with respect to active ingredient(s), dosage form, route of administration, strength, labeling, and conditions of use, among other characteristics. Co-Authors: Jenny Fielder.

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Development Bioequivalency Generic Drugs Production 242

FDA Law Blog

NOVEMBER 20, 2023

Of note, the new structure removes any separation between new and generic drug quality review offices. The Agency has high expectations of industry’s willingness to invest in and proactively address quality matters. The new parts of OPQ reflect that. It’s also clear that culture counts.

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Generic Drugs Manufacturing Drugs Research 59

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

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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FDA Approval Marketing Branding Generic Drugs 52

Camargo

MAY 10, 2021

The guidance goes on to generally describes the tools and the mechanics of using the tools for programs, including (but not limited to) Pre-Approval Inspections (PAIs), Pre-License Inspections (PLIs), Post-Approval Inspections (PoAIs), Surveillance Inspections, Follow-Up and Compliance Inspections, and Bioresearch Monitoring (BIMO) Inspections.

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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. Just like it was over a decade ago in Pliva v.

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FDA Approval Production Drugs Generic Drugs 40

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. Ensuring batch-to-batch consistency is a significant challenge. Determining the optimal dosage and administration route is more challenging.

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Development Drugs Manufacturing Immune Response 75

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.

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Regulation Manufacturing Medicine Drugs 52

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.

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Medicine Manufacturing Pharma Companies Production 246

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.

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Drugs Manufacturing Medicine Compliance 71

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