Generics

07
Apr

Regulatory Intelligence

How do companies keep up with the rapidly changing world of drug and device regulations?  Some companies have entire departments dedicated to these efforts.  Other companies have people doing it part-time, perhaps as an add-on to their primary jobs.  Some companies may not pay attention at all. Lachman offers a solution to this.  We develop […]

Read More
24
Mar

In Times of Crisis, Cyber Threats Increase – Be Wary

As the coronavirus spreads around the globe, unfortunately so do cyber-criminal attacks.  Cyber criminals see this as a golden opportunity to capitalize.  Hackers leverage the panic, confusion, and misinformation to transmit malware, breach computer networks, set up malicious websites, and launch social engineering attacks. Early on in the coronavirus pandemic, the Cybersecurity and Infrastructure Security […]

Read More
23
Mar

FDA to Exercise Enforcement Discretion for Certain Limited REMS ETASU Elements

Another FDA Guidance entitled Policy for Certain REMS Requirements During the COVID19 Public Health Emergency (here) provides another look into the complexity of the questions and the situations that arise when we are in the throes of a public health emergency (PHE) and the interplay of existing FDA requirements in addressing urgent need during the […]

Read More
21
Mar

ADE Relief During Pandemic – But Only if You Need It!

The guidances related to this COVID 19 pandemic (and I guess in preparation for the next one) are flying off the printers at the Agency.  The FDA issued this Guidance directly with no public comment on March 20, 2020.  It takes into consideration the potential impact of the pandemic on staffing level that may interfere […]

Read More
20
Mar

COVID-19 Guidances to Bypass Initial Public Comment Period

In a prepublication notice in the Federal Register published today (here), the FDA indicates that, since the COVID 19 pandemic has resulted in the declaration of a public health emergency by the President, and, through the regulatory authority given to the Secretary of Health and Human Services, the FDA will expedite important guidance on COVID […]

Read More
18
Mar

Mission Critical Only Inspections Starting on March 19

On March 10, 2020 FDA announced it was postponing all foreign inspections and on March 18, 2020, only 8 days later, FDA announced it was also stopping all domestic inspections unless mission critical until such time as it is deemed safe for FDA employees and their families as well as the employees of the firms […]

Read More
18
Mar

COVID-19 and Impact for Ongoing Clinical Trials – FDA Provides Guidance

With social distancing, borders closing, people self-quarantining at home, traveler screenings at airports, and people just trying to get home from abroad, perhaps only those contemplating starting or having an ongoing clinical study are thinking about or asking for guidance about what to do with clinical studies, while many of us are simply worried about […]

Read More
17
Mar

Flow Restrictor Recommendations for Oral Liquid Products

Being in the pharmaceutical business, we are all aware of the Consumer Product Safety Commission (CPSC) requirements for child-resistant containers.  We know that CPSC now regulates such child-resistant closures (CRCs), but the FDA requires firms to certify that the packages they claim to be child-resistant meet the CPSC regulations as well.  Most of us think […]

Read More
1 2 86