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…at the port entry, and exporters must report losses until a shipment has released at the port of export. The final rule establishes guidelines for determining whether a listed chemical…
By Ricardo Carvajal – Del Monte Fresh Produce N.A., Inc. (“Del Monte Fresh”) sued to invalidate an FDA import alert on cantaloupe from Productos Agricolas de Oriente, S.A. (“PAO”), a…
…process, has “stringent standards” against the issuance of prescriptions based on online consultations, and does not certify Canadian online pharmacies. Google also hired a third-party company to detect pharmacy advertisers’…
…enforcement. In general, food companies engaged in online marketing that is directed to children, or likely to appeal to children, are at the greatest risk. COPPA governs companies’ collection, use,…
…look. What is it? An online tool for reporting allegations of regulatory misconduct against medical device companies. Allegations may be submitted using a simple form, which provides anonymity for the…
…of Facebook’s new policy requiring that pharmaceutical manufacturers, telehealth companies, and online pharmacies apply for permission to advertise on Facebook. This new policy goes into effect on August 25, 2021….
…eliminating the “mail-in” option, believing that initial and renewal applications submitted online will be more effective for the agency and registrants. Requiring Online Submission of Applications for and Renewals of…
…expanded vaccine that treats all of the bacterial strains covered by the original vaccine plus additional ones. Like the original, the expanded vaccine is the only FDA-approved pneumococcal conjugate vaccine…
…metal/metal semi-constrained, with a cemented acetabular component, prosthesis. 22. 21 CFR 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis. 23. 21 CFR 890.5290(b) Shortwave diathermy (certain uses)….
…(later amended) Allergan, Inc. (“Allergan”) filed alleging premature notice concerning generic RESTASIS (cyclosporine ophthalmic emulsion) 0.05%. Allergan was seeking, among other things, a “Declaratory Judgment of False Paragraph IV Notification”…
…area of tobacco sales and market dynamics. The Committee recommends FDA’s Office of Criminal Investigations assist Federal, state, and local agencies in targeting the highest-level criminal tobacco trafficking organizations by…
…approach towards these imports from port to port. Commissioner Hamburg’s prepared remarks for the Center for Strategic and International Studies in February 2010, address almost the identical issues contained in…
…has actively and deliberately targeted a greater number of well-known, national brands. All advertisers under FTC jurisdiction are well-advised to review their use of online disclosures sooner rather than later. …
…on the final list. FDA’s notification also, separately and somewhat unrelated to the proposed list, clarifies its policy regarding orthopedic manual surgical instruments that are appropriately classified as Class I…
…(D-VI) (who is chairwoman of the Congressional Black Caucus Health Braintrust) and expresses the strong support of members of the Congressional Black Caucus for Section 37 of the House-passed version…