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18 Mar 2019, 10:57 am
“The FDA does not ‘accredit’ or ‘approve’ Section 503B outsourcing facilities or pharmaceutical ingredients, although the FDA does register and inspect such facilities,” including those of Sincerus, which hasn’t had an FDA objection. [read post]
21 Dec 2010, 11:00 am
Genzyme’s petition requested that FDA not approve Cobrek’s ANDA until the expiration of a second, superseding 30-month stay. [read post]
27 Aug 2008, 4:47 pm
" Subsection (b)(2) addresses documents required for inclusion in the joint appendix. [read post]
9 Jul 2009, 4:36 am
If the municipality does not have a chief of police, "law enforcement agency having jurisdiction" means the sheriff of the county where the municipality is located. [read post]
11 Apr 2024, 9:05 am
What does it mean for an organization to be operated for the promotion of social welfare? [read post]
1 Jan 2012, 11:42 am
This subdivision does not prohibit a resident who is not a member of the board from speaking on issues not on the agenda [read post]
11 Mar 2012, 4:43 pm
” (FDC Act § 505(q)(1)(G)). [read post]
14 Jun 2017, 4:43 pm
The report reflects the top 100 settlements since January 1, 1996, as of December 30, 2016. [read post]
18 May 2011, 9:31 am
Inclusion of this letter in this situation will help prevent delays. [read post]
24 Apr 2024, 11:23 am
Plaintiff's case with MHA was closed on October 30, 2020. [read post]
26 Oct 2011, 1:07 pm
This benefit doesn’t affect a huge number of people, but it does send an important message about diversity and inclusion — a message that gay lawyers greatly appreciate. [read post]
11 Sep 2011, 4:19 am
If an institution does not have a presence on a website, the institution must make the policy available in writing within 5 business days of any request. [read post]
Call for Papers for Special Edition of Violence Against Women journal – “Teaching Domestic Violence”
16 Mar 2012, 12:48 pm
Potential contributors to the special issue are asked to submit their manuscripts of no more than 30 double-spaced pages, inclusive of abstract, tables, figures, notes and references, written in APA style. [read post]
22 Aug 2012, 8:39 am
The existing bulkhead provisions are often too restrictive to accommodate a rooftop configuration that allows for the inclusion of these rooftop systems and/or equipment. [read post]
18 Feb 2019, 2:00 am
Does the process seem incongruent? [read post]
23 Feb 2021, 7:55 am
Rohl said in his affidavit he was approached at 6:30 p.m. and told the filing deadline was at midnight. [read post]
26 Feb 2024, 8:30 am
How does the statute define “seriously delinquent tax debt”? [read post]
28 Mar 2018, 2:52 am
See 775 ILCS 30. [read post]
21 Dec 2010, 10:00 am
As we previously reported, document corrections under Notice 2010-6 that are implemented before 2011 are treated as having been corrected on January 1, 2009, which can mean that any requirement of income inclusion under 409A as a condition of the relief would generally not apply. [read post]
12 May 2020, 5:47 pm
The inclusion of the last group is especially curious in light of the substantial numbers of Asians admitted through the regular admissions process. [read post]
