Remove Government Remove Packaging Remove Regulations
article thumbnail

How AI and LLMs are transforming drug discovery: part 1

Drug Target Review

The challenges lie in regulated industries where governance frameworks for standard quantitative models dont necessarily apply to LLMs. The challenges lie in regulated industries where governance frameworks for standard quantitative models don’t necessarily apply to LLMs.

article thumbnail

A Visual Guide to Gene Delivery

Codon

The first of these components is the therapeutic genetic payload, or cargo, which is designed to correct or regulate the disease-causing mutation, whether that means offering a healthy copy of a mutated gene or delivering precision-editing tools like CRISPR. Equally vital is the delivery vector, which carries this payload to specific cells.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Best CDMO Practices for Startups: Navigating the Complex World of Contract Development and Manufacturing

Drug Patent Watch

Take the time to clearly define your technical needs, from drug substance manufacturing to packaging requirements. A: First, try to address issues through open communication and your established governance structure. Q: How can I ensure my CDMO is staying compliant with evolving regulations?

article thumbnail

Companies Shipping Chemicals: “Know the One You’re Dancing With”

FDA Law Blog: Biosimilars

DEA seized five packages in Eagle Pass, Texas, identifying IMC Pro as the shipper containing 26.4 1-BOC-Piperidone is a DEA-regulated List 1 chemical while (2-Bromethyl) benzene is on DEAs longstanding, recently updated Special Surveillance List. The government determined that the chemicals had been imported into the U.S.

article thumbnail

More on the Impact of the FDA RIFs: How Information Disclosure will Start FOIA-lling Behind

FDA Law Blog: Biosimilars

federal law enacted in 1967 to promote transparency and accountability in the federal government by granting the public the right to request access to government records, subject to certain exemptions. FOIA is a U.S. In some cases, previously routine postings are delayed or going unpublished altogether.

FDA
article thumbnail

Baxter Releases Annual Corporate Responsibility Report Highlighting Global Impact

The Pharma Data

This pilot effort included employee training on circularity principles and identified ways to apply these concepts to manufacturing and packaging. A Task Force on Climate-related Financial Disclosures (TCFD) Index , providing a clear view into the company’s climate-related governance, risks, metrics, and strategy.

article thumbnail

Analysis Food Thank You FDA, USDA take first steps to define ultra-processed foods

Agency IQ

With the release of the RFI, the administration has begun to build a policy foundation upon which future government actions to address and restrict UPFs will likely occur. States have begun developing policies to restrict and regulate UPFs. The RFI also cites the MAHA assessment as a relevant background document justifying the request.

FDA