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FDA’s Proposal to Remove Oral Phenylephrine from the OTC Monograph Isn’t a Surprise but What is Left “Over-the-Counter”?

FDA Law Blog: Biosimilars

Along with the proposed order, FDA issued as a supporting document the “ Scientific Review Supporting Proposed Administrative Order ” in which it describes the scientific data on the efficacy, pharmacology, and safety of oral PE underlying its determination to issue the proposed order.

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How to ensure quality and compliance in clinical supply chain management

GMPSOP

To maintain the integrity and safety of these investigational products, you must adhere to Good Manufacturing Practice (GMP), FDA Clinical Trail Guidance Documents , and relevant ISO or EN standards. Additional documents included each month. Additional documents included each month. ensure traceability and compliance.

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Natco Pharma Limited -Walk-In Interview for Formulation Research & Development (OSD & Injectable) On 4th Feb’ 2023

Pharma Pathway

Candidate should have exposure in handling various dosage forms such as tablets and capsule (ER/ SR IR) / Injectables (Cytotoxic / High potent molecules /drug device combination products) Development of Formulation for ANDA and other regulatory submissions. Should have Excellent Oral and written communication and presentation skills.

Dosage 59
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Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales

FDA Law Blog: Biosimilars

12, 2012). “[W]hen the circumstances surrounding the presentation of a prescription would give rise to suspicion in a ‘reasonable professional,’ there is a duty to question the prescription.” The CDC has advised clinicians to carefully assess increasing total opioid dosage to greater than 50 MMEs per day). Holiday CVS, L.L.C.

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Pharmacists in Florida (and Elsewhere): Waive Prescribing Red Flags at Your Peril

FDA Law Blog: Biosimilars

DEA recently revoked the registration of Coconut Grove Pharmacy (“Coconut Grove”), like Gulf Med Pharmacy also in Florida, for its failure to resolve prescribing red flags and document such resolution. Coconut Grove Pharmacy; Decision and Order, 89 Fed. 50,372 , 50,377 (June 13, 2024). 50,372 at 50,372-73.

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Stability testing overview for Pharmaceutical products

GMPSOP

Stability and container closure systems Stability testing should be conducted on the proposed dosage form that is to be included in the container closure system (including, as appropriate, any secondary packaging and the container label). Additional documents included each month. Additional documents included each month.

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Understanding GFI #256: The 4 Takeaways That Matter to Your Veterinary Practice

epicur

The FDA recently finalized regulatory guidance for compounded animal medications from bulk drug substances for use in non-food-producing animals, impacting the way compounded drugs can be used, documented, ordered, and prescribed. Pharmacists must document why an FDA-approved or indexed product is not being used to compound the medication.