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…to this global problem. The IOM also recommends creation of a centralized public database of suspended and revoked wholesale pharmaceutical licenses. The report recommends that FDA create this national database…
By Karla L. Palmer – Last week, several congressional representatives announced the introduction of H.R. 3537, the “Synthetic Drug Control Act of 2015.” If enacted, the Synthetic Drug Control Act would…
…the dozen guidelines provided during the webinar as follows: Non-pharmacological therapy and non-opioid pharmacological therapy are preferred for chronic pain. Providers should only consider adding opioid therapy if expected benefits…
…the final rule for Sanitary Transportation of Human and Animal Food. Although FSMA directed FDA to issue this rule, the rule implements the Sanitary Food Transportation Act of 2005 (SFTA)….
…hearings, along with the ability to view documents filed by the parties in the public docket. For example, the Environmental Protection Agency, the Federal Trade Commission, and the National Labor…
…complaints, including minor to major medical events, but also complaints about non-medical issues such as off-taste or color of a product. Information in the database includes demographic (e.g., age, gender)…
…threshold for disclosure should be; how disclosures should be made for bulk, vending machine, and online purchases; how AMS should define very small or small packages for purposes of special…
…with a direct final rule. FDA ultimately withdrew the direct final rule because it received “significant adverse comment[s].” After considering the comments, on February 19, 2013, FDA issued a supplemental…
…to say that OTC hearing aids aren’t working to address the critical issue of hearing loss, it seems that almost two years is still not enough time to assess market…
…all records related to the Cafepharma.com postings. In two other letters unrelated to the Cafepharma.com postings, the Oversight and Investigations Subcommittee also requests detailed information from FDA and Merck/Schering-Plough on,…
…of substantial equivalence. Given the implications of receiving an NSE for cybersecurity alone, manufacturers and interested parties can still provide comments online regarding the draft guidance until May 13, 2024….
…issued for a legitimate medical purpose in the usual course of professional practice by . . . a practitioner who has conducted at least 1 in-person medical evaluation of the…
…address regulatory concerns associated with space limitations or tools that allow for real-time communications to present product information? How should companies address the potential volume of information shared on various…
…provides adequate protection if an identifiable individual discloses an adverse event and it turns out that AZ personnel do monitor the sidewiki, but lawyerly small print can’t protect against all…
…the present time, this class of drugs is limited to three Amgen products: Procrit, Epogen (both epoetin alfa) and Aranesp (darbepoetin alfa). FDA required Amgen to create a “risk management…