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News from the FDA
Patent Submission and Listing Requirements
The FDA amended its patent submission and listing requirements for new drug applications. The final rule clarifies the types of patents that must and must not be submitted and revises the declaration that NDA applicants must provide regarding their patents to help ensure that such applicants submit only appropriate patents. The final rule also revises the regulations regarding the effective date of approval for certain abbreviated new drug applications (ANDAs) and certain other new drug applications, known as 505(b)(2) applications, submitted under the Federal Food, Drug, and Cosmetic Act. In certain situations, Federal law bars FDA from making the approval of certain ANDA and 505(b)(2) applications effective for 30 months if the applicant has certified that the patent claiming a drug is invalid or will not be infringed, and the patent owner or NDA holder then brings suit for patent infringement. The final rule also states that there is only one opportunity for a 30-month stay in the approval date of each ANDA and 505(b)(2) application.
The final rule, effective on August 18, will make the patent submission and listing process more efficient as well as enhance the ANDA and 505(b)(2) application approval processes. The compliance date is Dec. 18, 2003, for the submission of information on polymorph patents.
For further information, contact Jarilyn Dupont, Office of Policy and Planning (HF-11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3360. The full text of the FDA announcement can be found at http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-15065.htm.
Comment Period Extended
The comment period for a proposed rule published in the Federal Register of March 14 (68 FR 12406) that would amend the agency's pre- and post-marketing safety reporting regulations for human drug and biological products has been extended to October 14. The FDA is taking this action in response to a request for more time to submit comments.
Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to [email protected] or on the Internet at http://accessdata.fda.gov/scripts/oc/dockets/commentdocket.cfm. For further information, go to http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-15341.htm.
Surgical Suture Devices: Final Rule
The FDA issed a final rule to amend the classification regulations for eight surgical suture devices previously reclassified into class II to specify a special control for those devices. The special control is an FDA guidance document entitled 'Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA' that identifies performance, testing, and labeling recommendations for the devices. The devices reclassified from class III to class II can be viewed at http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-13825.htm.
his rule became effective July 3.
OTC Skin Protectant Products: Final Monograph
A final rule in the form of a monograph establishing conditions under which over-the-counter (OTC) skin protectant drug products are generally recognized as safe and effective and not misbranded became effective June 4. The monograph includes OTC skin protectant drug products for minor cuts, scrapes, burns, chapped skin and lips, poison ivy, poison oak, poison sumac, and insect bites. The compliance date for products subject to parts 310 and 347 (21 CFR parts 310 and 347) with annual sales less than $25,000 is June 6, 2005. The compliance date for all other products subject to parts 310 and 347 is June 4, 2004. The compliance date for combination products containing skin protectant and sunscreen active ingredients in Sec. 347.20(d) and for all products subject to part 352 is stayed until further notice. For further information, go to http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-13751.htm.
Internal Analgesic Proposed Rule
The comment period on the FDA's proposal to amend the tentative final monograph for OTC internal analgesic, antipyretic, and antirheumatic (IAAA) drug products to include ibuprofen as a generally recognized safe and effective is reopened until Sept. 2, 2003.
The original comment period for this information closed Nov. 19, 2002. Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to
http://www.fda.gov/dockets/ecomments. For further information, see
http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-13914.htm.
FDA Approves Once-Daily Protease Inhibitor
The agency announced approval on June 20 of Reyataz (atazanavir sulfate), a protease inhibitor to be used in combination with other anti-retroviral agents for the treatment of patients with HIV infection. Reyataz is manufactured by Bristol-Myers Squibb. Approval of this drug will now allow patients access to a protease inhibitor that only needs to be taken once daily with food and has a low “pill burden” (two pills each day).
The FDA based its approval of Reyataz on data from two Phase 2 48-week trials and from 24-48 week data from Phase 3 studies. Results from these trials showed a decrease in viral load (the amount of HIV-1 virus circulating in plasma) and an increase in CD4 cell counts (a measure of immune cells created by the body) in patients taking Reyataz in combination with other anti-retroviral agents. Reyataz appears to have minimal impact on lipid parameters such as tryiglycerides and cholesterol.
The comment period for a proposed rule published in the Federal Register of March 14 (68 FR 12406) that would amend the agency's pre- and post-marketing safety reporting regulations for human drug and biological products has been extended to October 14. The FDA is taking this action in response to a request for more time to submit comments.
Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to FDADockets@ oc.fda.gov or on the Internet at http://accessdata.fda.gov/scripts/oc/dockets/commentdocket.cfm. For further information, go to http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-15341.htm.
http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-13825.htm http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-13751.htm
The comment period on the FDA's proposal to amend the tentative final monograph for OTC internal analgesic, antipyretic, and antirheumatic (IAAA) drug products to include ibuprofen as a generally recognized safe and effective is reopened until Sept. 2, 2003.
The original comment period for this information closed Nov. 19, 2002. Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. For further information, see http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-13914.htm.
The agency announced approval on June 20 of Reyataz (atazanavir sulfate), a protease inhibitor to be used in combination with other anti-retroviral agents for the treatment of patients with HIV infection. Reyataz is manufactured by Bristol-Myers Squibb. Approval of this drug will now allow patients access to a protease inhibitor that only needs to be taken once daily with food and has a low 'pill burden' (two pills each day).
The FDA based its approval of Reyataz on data from two Phase 2 48-week trials and from 24-48 week data from Phase 3 studies. Results from these trials showed a decrease in viral load (the amount of HIV-1 virus circulating in plasma) and an increase in CD4 cell counts (a measure of immune cells created by the body) in patients taking Reyataz in combination with other anti-retroviral agents. Reyataz appears to have minimal impact on lipid parameters such as tryiglycerides and cholesterol.
Patent Submission and Listing Requirements
The FDA amended its patent submission and listing requirements for new drug applications. The final rule clarifies the types of patents that must and must not be submitted and revises the declaration that NDA applicants must provide regarding their patents to help ensure that such applicants submit only appropriate patents. The final rule also revises the regulations regarding the effective date of approval for certain abbreviated new drug applications (ANDAs) and certain other new drug applications, known as 505(b)(2) applications, submitted under the Federal Food, Drug, and Cosmetic Act. In certain situations, Federal law bars FDA from making the approval of certain ANDA and 505(b)(2) applications effective for 30 months if the applicant has certified that the patent claiming a drug is invalid or will not be infringed, and the patent owner or NDA holder then brings suit for patent infringement. The final rule also states that there is only one opportunity for a 30-month stay in the approval date of each ANDA and 505(b)(2) application.
The final rule, effective on August 18, will make the patent submission and listing process more efficient as well as enhance the ANDA and 505(b)(2) application approval processes. The compliance date is Dec. 18, 2003, for the submission of information on polymorph patents.
For further information, contact Jarilyn Dupont, Office of Policy and Planning (HF-11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3360. The full text of the FDA announcement can be found at http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-15065.htm.
Comment Period Extended
The comment period for a proposed rule published in the Federal Register of March 14 (68 FR 12406) that would amend the agency's pre- and post-marketing safety reporting regulations for human drug and biological products has been extended to October 14. The FDA is taking this action in response to a request for more time to submit comments.
Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to [email protected] or on the Internet at http://accessdata.fda.gov/scripts/oc/dockets/commentdocket.cfm. For further information, go to http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-15341.htm.
Surgical Suture Devices: Final Rule
The FDA issed a final rule to amend the classification regulations for eight surgical suture devices previously reclassified into class II to specify a special control for those devices. The special control is an FDA guidance document entitled 'Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA' that identifies performance, testing, and labeling recommendations for the devices. The devices reclassified from class III to class II can be viewed at http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-13825.htm.
his rule became effective July 3.
OTC Skin Protectant Products: Final Monograph
A final rule in the form of a monograph establishing conditions under which over-the-counter (OTC) skin protectant drug products are generally recognized as safe and effective and not misbranded became effective June 4. The monograph includes OTC skin protectant drug products for minor cuts, scrapes, burns, chapped skin and lips, poison ivy, poison oak, poison sumac, and insect bites. The compliance date for products subject to parts 310 and 347 (21 CFR parts 310 and 347) with annual sales less than $25,000 is June 6, 2005. The compliance date for all other products subject to parts 310 and 347 is June 4, 2004. The compliance date for combination products containing skin protectant and sunscreen active ingredients in Sec. 347.20(d) and for all products subject to part 352 is stayed until further notice. For further information, go to http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-13751.htm.
Internal Analgesic Proposed Rule
The comment period on the FDA's proposal to amend the tentative final monograph for OTC internal analgesic, antipyretic, and antirheumatic (IAAA) drug products to include ibuprofen as a generally recognized safe and effective is reopened until Sept. 2, 2003.
The original comment period for this information closed Nov. 19, 2002. Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to
http://www.fda.gov/dockets/ecomments. For further information, see
http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-13914.htm.
FDA Approves Once-Daily Protease Inhibitor
The agency announced approval on June 20 of Reyataz (atazanavir sulfate), a protease inhibitor to be used in combination with other anti-retroviral agents for the treatment of patients with HIV infection. Reyataz is manufactured by
The FDA based its approval of Reyataz on data from two Phase 2 48-week trials and from 24-48 week data from Phase 3 studies. Results from these trials showed a decrease in viral load (the amount of HIV-1 virus circulating in plasma) and an increase in CD4 cell counts (a measure of immune cells created by the body) in patients taking Reyataz in combination with other anti-retroviral agents. Reyataz appears to have minimal impact on lipid parameters such as tryiglycerides and cholesterol.
The comment period for a proposed rule published in the Federal Register of March 14 (68 FR 12406) that would amend the agency's pre- and post-marketing safety reporting regulations for human drug and biological products has been extended to October 14. The FDA is taking this action in response to a request for more time to submit comments.
Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to FDADockets@ oc.fda.gov or on the Internet at http://accessdata.fda.gov/scripts/oc/dockets/commentdocket.cfm. For further information, go to http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-15341.htm.
http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-13825.htm http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-13751.htm
The comment period on the FDA's proposal to amend the tentative final monograph for OTC internal analgesic, antipyretic, and antirheumatic (IAAA) drug products to include ibuprofen as a generally recognized safe and effective is reopened until Sept. 2, 2003.
The original comment period for this information closed Nov. 19, 2002. Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. For further information, see http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-13914.htm.
The agency announced approval on June 20 of Reyataz (atazanavir sulfate), a protease inhibitor to be used in combination with other anti-retroviral agents for the treatment of patients with HIV infection. Reyataz is manufactured by
The FDA based its approval of Reyataz on data from two Phase 2 48-week trials and from 24-48 week data from Phase 3 studies. Results from these trials showed a decrease in viral load (the amount of HIV-1 virus circulating in plasma) and an increase in CD4 cell counts (a measure of immune cells created by the body) in patients taking Reyataz in combination with other anti-retroviral agents. Reyataz appears to have minimal impact on lipid parameters such as tryiglycerides and cholesterol.
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.