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Hello Colleagues, Can an ANDA reference more than 1 RLD? Thank you. David Lucking ------------------------------ David Lucking Coral Gables FL United States ------------------------------

Hello Colleagues, Would the FDA approve an ANDA for a generic product that is not identical to the RLD in terms of impurity profile? Thank you. ------------------------------ David Lucking Coral Gables FL United States ------------------------------

Helle colleagues, What are the requirements for a company to market their own unbranded authorized biosimilar or biologic product? Thank you. Best regards. Davids Lucking ------------------------------ David Lucking Coral Gables FL United States ------------------------------

Dear Colleagues, If a drug products has been placed on the discontinued list for a short period of time is it still necessary to submit, annual reports, safety reports and lot distribution reports while the product is on the discontinued list? Thank you. ------------------------------ David ...

What type of submission would be required to add an alcohol swab for disinfecting the skin to a carton containing an autoinjector (CBE-30, PAS etc) Would the alcohol swab need to be approved via a 510k? David Lucking Virus-free. www.avast.com