Dear Doctor definition
Examples of Dear Doctor in a sentence
Such actions may include, for example, change in label, Dear Doctor letter, trial on hold for clinical safety reasons and the like.
If: (i) any Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled; (ii) a court of competent jurisdiction orders a Recall; or (iii) Client determines that any Product should be Recalled or that a "Dear Doctor" letter is required relating the restrictions on the use of any Product, then Patheon will co-operate as reasonably required by Client, having regard to all Applicable Laws.
If (i) any Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about the Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client determines that any Product should be Recalled or that a "Dear Doctor" letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by Client, having regard to all applicable laws and regulations.
If (i) any Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client determines that any Product should be Recalled or that a "Dear Doctor" letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by Client, having regard to all applicable laws and regulations.
If (i) any Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client determines that any Product should be Recalled or that a "Dear Doctor" letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by Client, having regard to all cGMPs and Applicable Laws.
Within ten (10) days after the signing of this Agreement by both Parties, Roche shall pay to Trimeris the Past Settlement Amount and Trimeris shall pay to Roche the Dear Doctor Letter Sharing Payment.
If (i) any Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client determines that any Product should be Recalled or that a "Dear Doctor" letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by Client, having regard to all Applicable Laws.
During that period there is not any "Dear Doctor" letters issued by the US FDA regarding this Product.
Each Party shall attempt to immediately notify the other (via their respective appointed pharmacovigilance representatives) upon being contacted by a Regulatory Authority on any significant regulatory matter pertaining to the safety profile of the Product or to the subject-matter of this Pharmacovigilance Agreement, including but not limited to risk management communication, Dear Doctor Letters, urgent safety restrictions or labelling changes, to ensure that communication between the Parties is aligned.
In the event (but only in the event) (i) any governmental agency or Regulatory Authority issues a request, directive or order that Product be recalled, (ii) a court of competent jurisdiction orders that Product be recalled or (iii) Spectrum reasonably determines that Product should be recalled or withdrawn from the market or that a "Dear Doctor" letter should be sent relating to use of Product, Spectrum shall take all appropriate remedial actions with respect thereto.