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Is License Compulsory For Starting Pharmaceutical Business In India?

Fossil Remedies

To launch the best PCD pharma franchise company, you will have to acquire the necessary licenses from authorities. The next important thing is the license. Every pharma company needs a drug license number to begin distribution, marketing, and manufacturing activities. License required to start a Pharmaceutical Business in India.

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Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Camargo

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

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Ipsen plans sale of consumer health business for €350m

pharmaphorum

If consummated, the deal would bring in around €350 million for Ipsen , leaving the company as a specialty pharma pure-play in cancer, rare diseases and neuroscience and ending its strategy of adopting a combined prescription and over-the-counter (OTC) medicines business model. billion takeover of Clementia Pharma in 2019.

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What Makes a Food Product Vegan?

XTalks

Nowadays, the word’s meaning is commonly extended to refer to non-food products—such as clothing, cosmetics, and medicine—that are made without animal-derived substances. The word vegan was initially defined as a diet free of animal-based foods (such as meat, dairy products, eggs and honey.)

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A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). The PR states that LDTs are not the “practice of medicine,” with which FDA generally may not interfere.

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PhRMA’s Lawsuit Against Section 804 Ignores Statute’s Permissive Position on Personal Importation

Pharmacy Checkers

In late September, Secretary Azar, in a final rule , certified that importing drugs from Canada, subject to Section 804 of the Food, Drug and Cosmetic Act (Section 804), 21 U.S.C. In its lawsuit to stop wholesale drug importation programs that could help lower U.S.

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Pfizer to Provide U.S. Government with an Additional 3.7 Million Treatment Courses of PAXLOVID™ to Help Combat COVID-19

Pfizer

PAXLOVID may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs. The state-licensed pharmacist should refer an individual patient for clinical evaluation (e.g., COVID-19 Medicines Partnerships.

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