CCN Final RuleConsumer-Directed AdvertisementsDrug of ChoiceDrug Name SizeFDA-Approved Launch Information“New”Package InsertsPost-marketing ReportingPresentation of InformationPress ReleasesPre-distribution SubmissionsReminder AdvertisementsMiscellaneous Questions CCN Final Rule When does the Clear, Conspicuous and […]

On June 24, 2019, FDA issued a final guidance for industry entitled Providing Regulatory Submissions in Electronic and Non-Electronic Format–Promotional Labeling and Advertising Materials for Human […]

Docket Number: FDA-2024-D-1829 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance provides details about the […]

Acyclovir Update Dosage and Administration, Clinical Pharmacology, and Adverse Reactions sections of the label with information that dosing for neonatal HSV should be based on postmenstrual […]

Delivery Method: VIA UNITED PARCEL SERVICE Product: Drugs Recipient: Recipient Name Steven D. Garner Recipient Title Owner Safari Stem Cell, LLC 2402 Marina Bay Drive, Unit […]

Delivery Method: VIA Electronic Mail Reference #: 320-24-37 Product: Drugs Recipient: Recipient Name Mr. Koos Veel Recipient Title Managing Director Aruba Aloe Balm N.V. Pitastraat 115OranjestadAruba […]

Product: Drugs Recipient: Recipient Name Patrick Inglot Recipient Title CEO Ward Smelling Salts 719 Heritage Blvd. WLethbridge AB T1K7E6Canada [email protected] Issuing Office: Center for Drug Evaluation […]