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Pharmaceutical Industry Applications

King & Spalding

FDA Issues Draft Guidance on Use of “Generally Accepted Scientific Knowledge” to Support Drug and Biologic Applications

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Could Help to Streamline Development and Approval - On May 25, 2023, the Food and Drug Administration (“FDA” or the “Agency”) announced the availability of a new Draft Guidance for Industry, Generally Accepted Scientific...more

Foley Hoag LLP - Cannabis and the Law

Ohio Prepares for Dispensary Application Round

With much of the cannabis oriented media focusing on the flurry of adult use bills and opportunities, it is easy to overlook that many states are doubling down on their medical marijuana infrastructure. For instance, over...more

Hogan Lovells

Complementary Medicines: the way forward

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According to a recent report published by Grand View Research, Inc., it is expected that by 2026, the global complementary and alternative medicine (CAM) industry will generate over USD 200 billion. The CAM industry, which...more

Smart & Biggar

Health Canada updates Guidance Document: The Management of Drug Submissions and Applications

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On July 25, 2019, Health Canada released an updated version of the Guidance Document: The Management of Drug Submissions and Applications....more

Hogan Lovells

FDA issues benefit-risk framework for assessing opioid drug applications, announces public meeting

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Agency seeks input on “comparative advantage” requirement for new opioids - Yesterday, as part of its ongoing efforts to combat the current opioid crisis, FDA published a draft guidance, “Opioid Analgesic Drugs:...more

Hogan Lovells

The FDA now offers cGMP Declarations

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The United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Export Certificate office, a new online application. ...more

Knobbe Martens

China Drug Administration Proposes Pharmaceutical Data Protection Guidelines

Knobbe Martens on

On April 26, 2018, the China Drug Administration (CDA) released a draft guideline of implementing rules on pharmaceutical data exclusivity for public comments. The draft guideline expands the scope of data protection from...more

Goodwin

FDA Releases New “Refuse to File” Guidance

Goodwin on

The FDA has announced a draft guidance, titled “Refuse to File: NDA and BLA Submissions to CDER.” The guidance is intended to clarify the circumstances where the CDER (Center for Drug Evaluation and Research) may refuse to...more

Hogan Lovells

The MHRA issues new guidance concerning common issues in clinical trial applications

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On 22nd March 2017, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published a guidance (“Guidance“) identifying the most common issues that the Agency has encountered during the validation and review of...more

Hogan Lovells

EMA post-authorisation procedural advice for users of the centralised procedure

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On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of the centralised procedure (“the guidance...more

Hogan Lovells

UK MHRA publishes “top tips” for manufacturing authorisation applicants

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The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on common mistakes made by applicants, to help reduce...more

Manatt, Phelps & Phillips, LLP

Manatt on Health Reform: Weekly Highlights - September 2016 #4

Marylanders can shop for coverage through the Marketplace’s new mobile app; Michigan expansion enrollees report increased access to care and improved health; and survey finds states’ eligibility and enrollment systems...more

Akerman LLP - Marks, Works & Secrets

Overclaiming in Trademark Applications: “Full Line of …”

In Ferring B.V. v. Fera Pharmaceuticals, LLC, the Eastern District of New York was called upon to determine the importance of the United States Patent and Trademark Office’s Trademark Manual of Examining Procedure (“TMEP”)...more

K&L Gates LLP

FDA Accepts First Biosimilar Application Filed under Section 351(k) of the Public Health Service Act

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Biologics are large molecules made from, derived from, or extracted from a natural source such as a human, animal, or microorganism that are used in the treatment, diagnosis, or prevention of disease. Biologics include...more

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