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News from the FDA
Notice of Public Workshops, Drug/Biological Products
A public workshop to discuss risk management activities for drug and biological products (excluding blood products other than plasma derivatives) has been announced. The purpose of the workshop is to present FDA's current thoughts on risk management activities and to solicit views from the public.
To facilitate public input and discussion, FDA is issuing for review and comment three concept papers that focus on risk assessment, risk management, and pharmaco-vigilance. The input received at the workshop and from comments on the concept papers will be considered in drafting guidance for industry.
The concept papers are available at FDA's Dockets Management Branch and on the Internet at www.fda.gov/cder/meeting/riskmanagement.htm.
Revision to the General Safety Requirements for Biological Products
The biologics regulations regarding general biological products standards are being amended by the FDA, which is adding an administrative procedure for obtaining exemptions from the general safety test (GST) requirements. FDA is taking this action because the GST may not be relevant or necessary for certain biological products. The rule will permit manufacturers of biological products to apply for an exemption from the GST requirement provided they submit information to demonstrate that they use appropriate production controls and quality assurance safeguards. This rule is effective May 5, 2003.
The final rule codifies, at 21 CFR Sec. 610.11(g)(2), an administrative procedure under which manufacturers of biological products may request and obtain exemptions from the GST. Manufacturers wishing to obtain an exemption to the GST for a particular product should contact the appropriate CBER product division for specific information regarding how to apply and what information should be included in the application or supplemental application.
Notice of Public Workshops, Drug/Biological Products
A public workshop to discuss risk management activities for drug and biological products (excluding blood products other than plasma derivatives) has been announced. The purpose of the workshop is to present FDA's current thoughts on risk management activities and to solicit views from the public.
To facilitate public input and discussion, FDA is issuing for review and comment three concept papers that focus on risk assessment, risk management, and pharmaco-vigilance. The input received at the workshop and from comments on the concept papers will be considered in drafting guidance for industry.
The concept papers are available at FDA's Dockets Management Branch and on the Internet at www.fda.gov/cder/meeting/riskmanagement.htm.
Revision to the General Safety Requirements for Biological Products
The biologics regulations regarding general biological products standards are being amended by the FDA, which is adding an administrative procedure for obtaining exemptions from the general safety test (GST) requirements. FDA is taking this action because the GST may not be relevant or necessary for certain biological products. The rule will permit manufacturers of biological products to apply for an exemption from the GST requirement provided they submit information to demonstrate that they use appropriate production controls and quality assurance safeguards. This rule is effective May 5, 2003.
The final rule codifies, at 21 CFR Sec. 610.11(g)(2), an administrative procedure under which manufacturers of biological products may request and obtain exemptions from the GST. Manufacturers wishing to obtain an exemption to the GST for a particular product should contact the appropriate CBER product division for specific information regarding how to apply and what information should be included in the application or supplemental application.
Strategy vs. Tactics: Two Sides of a Difficult Coin
With each successive large-scale cyber attack, it is slowly becoming clear that ransomware attacks are targeting the critical infrastructure of the most powerful country on the planet. Understanding the strategy, and tactics of our opponents, as well as the strategy and the tactics we implement as a response are vital to victory.
'Huguenot LLC v. Megalith Capital Group Fund I, L.P.': A Tutorial On Contract Liability for Real Estate Purchasers
In June 2024, the First Department decided Huguenot LLC v. Megalith Capital Group Fund I, L.P., which resolved a question of liability for a group of condominium apartment buyers and in so doing, touched on a wide range of issues about how contracts can obligate purchasers of real property.
The Article 8 Opt In
The Article 8 opt-in election adds an additional layer of complexity to the already labyrinthine rules governing perfection of security interests under the UCC. A lender that is unaware of the nuances created by the opt in (may find its security interest vulnerable to being primed by another party that has taken steps to perfect in a superior manner under the circumstances.
CoStar Wins Injunction for Breach-of-Contract Damages In CRE Database Access Lawsuit
Latham & Watkins helped the largest U.S. commercial real estate research company prevail in a breach-of-contract dispute in District of Columbia federal court.