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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.
COVID-19 and Lease Negotiations: Early Termination Provisions
During the COVID-19 pandemic, some tenants were able to negotiate termination agreements with their landlords. But even though a landlord may agree to terminate a lease to regain control of a defaulting tenant's space without costly and lengthy litigation, typically a defaulting tenant that otherwise has no contractual right to terminate its lease will be in a much weaker bargaining position with respect to the conditions for termination.
How Secure Is the AI System Your Law Firm Is Using?
What Law Firms Need to Know Before Trusting AI Systems with Confidential Information In a profession where confidentiality is paramount, failing to address AI security concerns could have disastrous consequences. It is vital that law firms and those in related industries ask the right questions about AI security to protect their clients and their reputation.
Pleading Importation: ITC Decisions Highlight Need for Adequate Evidentiary Support
The International Trade Commission is empowered to block the importation into the United States of products that infringe U.S. intellectual property rights, In the past, the ITC generally instituted investigations without questioning the importation allegations in the complaint, however in several recent cases, the ITC declined to institute an investigation as to certain proposed respondents due to inadequate pleading of importation.
Authentic Communications Today Increase Success for Value-Driven Clients
As the relationship between in-house and outside counsel continues to evolve, lawyers must continue to foster a client-first mindset, offer business-focused solutions, and embrace technology that helps deliver work faster and more efficiently.
The Power of Your Inner Circle: Turning Friends and Social Contacts Into Business Allies
Practical strategies to explore doing business with friends and social contacts in a way that respects relationships and maximizes opportunities.