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Product-specific Draft Bioquivalence Guides
[64 Words]
[ Price : $8.95]
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| Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that provide product-specific recommendations on bioequivalence studies to support ANDAs. |
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11/08/2021
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MedWatch Info Collection Extension
[73 Words]
[ Price : $8.95]
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| Federal Register notice: FDA sends to OMB an information collection extension entitled “MedWatch: The FDA Medical Products Reporting Program.” |
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11/08/2021
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House Probes FDA/McKinsey Conflicts of Interest
[414 Words]
[ Price : $8.95]
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| The House Oversight and Reform Committee requests information on FDA’s consulting contracts with McKinsey due to potential conflicts with consulting company’s role in advising opioid maker Purdue while also advising FDA on its regulatory actions involving the drugs. |
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11/08/2021
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Animal Drug Regs Amended for Application Actions
[76 Words]
[ Price : $8.95]
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| Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions for new animal drug and abbreviated new animal drug applications during April, May, and June. |
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11/08/2021
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Eton/Azurity NDA Approved for Eprontia
[92 Words]
[ Price : $8.95]
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| FDA approves an Eton Pharmaceuticals and Azurity Pharmaceuticals NDA for Eprontia (topiramate) oral solution, 25mg/mL, indicated as a monotherapy for treating certain seizures. |
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11/08/2021
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Info Collection Revision on Drug Reporting
[117 Words]
[ Price : $8.95]
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| Federal Register notice: FDA sends to OMB an information collection revision for a guidance entitled “Postmarketing Adverse Experience Reporting and Recordkeeping for Drug and Biologics Products.” |
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11/05/2021
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Animal Drug Approval Docs Available
[80 Words]
[ Price : $8.95]
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| Federal Register notice: FDA amends the animal drug regulations to reflect recent application-related actions for new animal drug applications and abbreviated new animal drug applications. |
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11/05/2021
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7-Item 483 Issued to ACRX Specialty
[97 Words]
[ Price : $8.95]
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| FDA issues a seven-item Form FDA-483 to ACRX Specialty (Las Vegas, NV) after finding GMP problems during an inspection in July. |
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11/05/2021
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