
This week's key regulatory actions: the SEC settles the Adani bribery case and drops its 50-year 'no-deny' settlement policy; the FDA approves the first-ever hepatitis delta treatment and opens BHT/ADA food additive reviews; plus new SEC rule proposals that could end mandatory quarterly reporting.

| Rule action | Type | Date | Key change |
|---|---|---|---|
| Optional semiannual reporting | Proposed | May 5 | Companies may swap quarterly 10-Qs for a new Form 10-S |
| Registered offering overhaul | Proposed | May 19 | Shelf-offering access, blue-sky preemption, large-filer threshold raised to $2B |
| No-deny policy rescission | Final rule | May 18 | Settling defendants may now publicly contest SEC allegations |


| Company | Issuing office | Subject |
|---|---|---|
| Sato Pharmaceutical Co., Ltd. | CDER | CGMP/Drugs — adulteration, OTC |
| GC America, Inc. | CDER | CGMP/Finished pharmaceuticals — adulteration |
| Alchymars ICM SM Private Limited (India) | CDER | CGMP/Active pharmaceutical ingredient — adulteration |
| GSC Products, LLC | CDER | Unapproved new drugs / misbranded / OTC |
| Aja Health and Wellness Inc. | CDER | Unapproved new drug / misbranded |
| gethyppe.com | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act violations |
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